e10vq

FORM 10-Q

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934

For quarterly period ended March 31, 2009 Commission File Number 0-22962

HUMAN GENOME SCIENCES, INC.

(Exact name of registrant)


Delaware (State of organization)		22-3178468 (I.R.S. Employer Identification Number)

14200 Shady Grove Road, Rockville, Maryland 20850-7464
(Address of principal executive offices and zip code)

(301) 309-8504
(Registrant’s telephone number)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.
Yes þ No o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes o No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):


Large accelerated filer þ		Accelerated filer o		Non-accelerated filer o (Do not check if a smaller reporting company)		Smaller reporting company o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o No þ

The number of shares of the registrant’s common stock outstanding on March 31, 2009 was 135,790,040.

PART I. FINANCIAL INFORMATION

HUMAN GENOME SCIENCES, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS


	Three months ended March 31,
				2008
	2009			(Restated)
	(dollars in thousands, except share and per
	share amounts)
Revenue:
Product sales	$	127,769		$	—
Manufacturing and development services		29,116			—
Research and development collaborative agreements		20,392			12,275


Total revenue		177,277			12,275


Costs and expenses:
Cost of product sales		8,177			—
Cost of manufacturing and development services		3,351			—
Research and development expenses		53,675			72,691
General and administrative expenses		14,279			16,011


Total costs and expenses		79,482			88,702


Income (loss) from operations		97,795			(76,427	)
Investment income		4,296			6,707
Interest expense		(15,730	)		(15,517	)
Gain on extinguishment of debt		38,873			—
Gain on sale of long-term equity investment		5,259			32,518
Other expense		(680	)		—


Income (loss) before taxes		129,813			(52,719	)
Provision for income taxes		—			—


Net income (loss)	$	129,813		$	(52,719	)


Basic net income (loss) per share	$	0.96		$	(0.39	)


Diluted net income (loss) per share	$	0.85		$	(0.39	)


Weighted average shares outstanding, basic		135,755,471			135,284,778


Weighted average shares outstanding, diluted		163,423,487			135,284,778

The accompanying Notes to Consolidated Financial Statements are an integral part hereof.

HUMAN GENOME SCIENCES, INC.

CONSOLIDATED BALANCE SHEETS


				December 31,
	March 31,			2008
	2009			(Restated)
	(dollars in thousands)
Assets
Current assets:
Cash and cash equivalents	$	93,094		$	15,248
Short-term investments		97,979			22,691
Accounts receivable		38,506			2,871
Collaboration receivables		12,885			22,076
Prepaid expenses and other current assets		5,426			5,280

Total current assets		247,890			68,166

Marketable securities		138,210			265,640
Property, plant and equipment (net of accumulated depreciation and amortization)		273,863			274,315
Restricted investments		67,569			69,360
Long-term equity investments		2,516			2,606
Other assets		5,317			6,745

TOTAL ASSETS	$	735,365		$	686,832


Liabilities and Stockholders’ Deficit
Current liabilities:
Accounts payable and accrued expenses	$	68,773		$	55,434
Accrued payroll and related taxes		14,528			18,574
Accrued exit expenses		2,025			2,952
Deferred revenues		44,455			43,746

Total current liabilities		129,781			120,706

Convertible subordinated debt		334,269			417,597
Lease financing		247,061			246,477
Deferred revenues, net of current portion		18,630			29,563
Accrued exit expenses, net of current portion		1,831			2,075
Other liabilities		7,241			6,718

Total liabilities		738,813			823,136


Stockholders’ deficit:
Preferred stock		—			—
Common stock		1,358			1,357
Additional paid-in capital		2,062,107			2,059,154
Accumulated other comprehensive loss		(4,401	)		(4,490	)
Accumulated deficit		(2,062,512	)		(2,192,325	)

Total stockholders’ deficit		(3,448	)		(136,304	)

TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT	$	735,365		$	686,832

The accompanying Notes to Consolidated Financial Statements are an integral part hereof.

HUMAN GENOME SCIENCES, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS


	Three months ended March 31,
				2008
	2009			(Restated)
	(dollars in thousands)
Cash flows from operating activities:
Net income (loss)	$	129,813		$	(52,719	)
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Stock-based compensation expense		2,935			4,463
Depreciation and amortization		5,332			5,159
Amortization of debt discount		6,398			5,854
Gain on extinguishment of long-term debt		(38,873	)		—
Gain on sale of long-term equity investment		(5,259	)		(32,518	)
Accrued interest on short-term investments, marketable securities and restricted investments		1,186			939
Gain on sale of investments and marketable securities		(889	)		(40	)
Non-cash expenses and other		1,407			832
Changes in operating assets and liabilities:
Accounts receivable		(35,635	)		—
Collaboration receivables		9,191			3,562
Prepaid expenses and other assets		72			1,276
Accounts payable and accrued expenses		13,957			15,650
Accrued payroll and related taxes		(4,046	)		(3,531	)
Accrued exit expenses		(1,323	)		(395	)
Deferred revenues		(10,224	)		(11,305	)
Other liabilities		505			526

Net cash provided by (used in) operating activities		74,547			(62,247	)

Cash flows from investing activities:
Purchase of short-term investments and marketable securities		(36,393	)		(10,451	)
Proceeds from sale and maturities of short-term investments and marketable securities		87,832			57,889
Proceeds from sale of long-term equity investment		5,259			47,336
Capital expenditures — property, plant and equipment		(5,122	)		(2,391	)
Release of restricted investments		2,507			—

Net cash provided by investing activities		54,083			92,383

Cash flows from financing activities:
Purchase of restricted investments		(4,468	)		(12,681	)
Proceeds from sale and maturities of restricted investments		3,696			11,893
Extinguishment of long-term debt		(49,998	)		—
Proceeds from issuance of common stock		—			3,424
Purchase of treasury stock		(14	)		(105	)

Net cash provided by (used in) financing activities		(50,784	)		2,531

Net increase in cash and cash equivalents		77,846			32,667
Cash and cash equivalents — beginning of period		15,248			34,815

Cash and cash equivalents — end of period	$	93,094		$	67,482

The accompanying Notes to Consolidated Financial Statements are an integral part hereof.

HUMAN GENOME SCIENCES, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

For the Quarter Ended March 31, 2009

(dollars in thousands, except per share data)

Note 1. Summary of Significant Accounting Policies

Basis of presentation

The accompanying unaudited consolidated financial statements of Human Genome Sciences, Inc. (the “Company”) have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information. In the opinion of the Company’s management, the consolidated financial statements reflect all adjustments necessary to present fairly the results of operations for the three months ended March 31, 2009 and 2008, the Company’s financial position at March 31, 2009, and the cash flows for the three months ended March 31, 2009 and 2008. These adjustments are of a normal recurring nature. Certain notes and other information have been condensed or omitted from the interim consolidated financial statements presented in this Quarterly Report on Form 10-Q. Therefore, these financial statements should be read in conjunction with the Company’s 2008 Annual Report on Form 10-K.

The results of operations for the three months ended March 31, 2009 are not necessarily indicative of future financial results. The Company anticipates that any significant revenue or income through at least 2010 may be limited to ABthrax revenue, payments under collaboration agreements (to the extent milestones are met), cost reimbursements from GSK and Novartis, payments from the license of product rights, payments under manufacturing agreements, such as its agreement with Hospira, Inc., investment income and other payments from other collaborators and licensees under existing or future arrangements, to the extent that the Company enters into any future arrangements. The Company expects its ABthrax product sales under the current contract to be significantly lower for the remainder of 2009. The Company also expects to continue to incur substantial expenses relating to its research and development efforts. As a result, the Company expects to incur significant losses over the next several years unless it is able to realize additional revenues under existing or any future agreements. The timing and amounts of such revenues, if any, cannot be predicted with certainty and will likely fluctuate sharply. Results of operations for any period may be unrelated to the results of operations for any other period.

The Company’s significant accounting policies are described in Note B of the Notes to the Consolidated Financial Statements included in its Annual Report on Form 10-K for the year ended December 31, 2008. In addition, the following additional significant accounting policies are now applicable:

Revenue

Product sales

Revenue from product sales is recognized when persuasive evidence of an arrangement exists, title to product and associated risk of loss has passed to the customer, the price is fixed or determinable, collection from the customer is reasonably assured, and the Company has no further performance obligations.

Manufacturing and development services

As part of its ABthrax contract with the United States Government and the Biomedical Advanced Research and Development Authority (“BARDA”), the Company performed a variety of drug development services primarily relating to the conduct of animal and human studies. Upon BARDA’s acceptance of the initial ABthrax delivery, the Company became entitled to bill the U.S. Government for the drug development work previously performed, and recorded this as manufacturing and development services revenue during the three months ended March 31, 2009. The Company will record additional development revenue as services are performed.

HUMAN GENOME SCIENCES, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

For the Quarter Ended March 31, 2009

(dollars in thousands, except per share data)

Note 1. Summary of Significant Accounting Policies (continued)

The Company has entered into agreements for manufacturing process development, clinical and commercial supply of certain biopharmaceutical products. Revenue under these agreements is recognized as services are performed or products delivered, depending on the nature of the work contracted, using a proportional performance method of accounting. Performance is assessed using output measures such as units-of-work performed to date as compared to total units-of-work contracted. Advance payments received in excess of amounts earned are classified as deferred revenue until earned.

Cost of Sales

Cost of product sales

The Company does not capitalize inventory costs associated with commercial supplies of drug product until it has received marketing approval from the FDA, or in the case of ABthrax, receives the authorization to ship to the Strategic National Stockpile. Prior to these approvals or authorizations, the cost of manufacturing drug product is recognized as research and development expenses in the period that the cost was incurred. Therefore, pre-approval manufacturing costs are not included in cost of product sales when revenue is recognized from the sale of that drug product. Cost of product sales includes royalties payable to third parties based on the sales levels of certain products.

Cost of manufacturing and development services

Cost of manufacturing and development services represents costs associated with the Company’s contract manufacturing arrangements and other development services. The costs associated with work previously performed to conduct animal and human studies for ABthrax were recognized as research and development expenses in the period that the costs were incurred. Therefore, these pre-acceptance development costs are not included in cost of manufacturing and development services for the three months ended March 31, 2009. The Company will record additional ABthrax development services costs as incurred.

Recent Accounting Pronouncements

In April 2009 the Financial Accounting Standards Board (“FASB”) issued three related Staff Positions: (i) FSP FAS 157-4, Determining Fair Value When the Volume and Level of Activity for the Asset or Liability have Significantly Decreased and Identifying Transactions That Are Not Orderly (“FSP 157-4”), (ii) FSP FAS 115-2, Recognition and Presentation of Other-Than-Temporary Impairments (“FSP 115-2”), and (iii) FSP FAS 107-1, Interim Disclosures about Fair Value of Financial Instruments (“FSP 107-1”). FSP 157-4 provides guidance on how to determine the fair value of assets and liabilities under Statement of Financial Accounting Standards (“SFAS”) No. 157, Fair Value Measurements (“SFAS No. 157”) in the current economic environment and reemphasizes that the objective of a fair value measurement remains an exit price. If the Company were to conclude that there has been a significant decrease in the volume and level of activity of the asset or liability in relation to normal market activities, quoted market values may not be representative of fair value and the Company may conclude that a change in valuation technique or the use of multiple valuation techniques may be appropriate. FSP 115-2 modifies the requirements for recognizing other-than-temporarily impaired debt securities and revises the existing impairment model for such securities, by modifying the current intent and ability indicator in determining whether a debt security is other-than-temporarily impaired. FSP 107-1 enhances the disclosure of instruments under the scope of SFAS No. 157 for both interim and annual periods. The Company is currently evaluating these Staff Positions, which will be effective for interim and annual periods ending after June 15, 2009.

HUMAN GENOME SCIENCES, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

For the Quarter Ended March 31, 2009

(dollars in thousands, except per share data)

Note 1. Summary of Significant Accounting Policies (continued)

In June 2008, the FASB ratified EITF Issue No. 07-5, Determining Whether an Instrument (or Embedded Feature) Is Indexed to an Entity’s Own Stock (“EITF No. 07-5”). EITF No. 07-5 mandates a two-step process for evaluating whether an equity-linked financial instrument or embedded feature is indexed to the entity’s own stock. The adoption of EITF 07-5 as of January 1, 2009 had no material effect on the Company’s consolidated results of operations, financial position or liquidity.

In February 2008, the FASB issued Staff Position No. 157-2, Effective Date of FASB Statement No. 157, which delayed the effective date of SFAS 157 for most non-financial assets and non-financial liabilities until fiscal years beginning after November 15, 2008. The implementation of SFAS 157 for non-financial assets and non-financial liabilities had no material effect on the Company’s consolidated results of operations, financial position or liquidity.

Note 2. Adoption of FASB Staff Position No. APB 14-1 (“FSP APB 14-1”)

In 2008, FASB issued Staff Position No. APB 14-1, Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement) (“FSP APB 14-1”). FSP APB 14-1 requires that the liability and equity components of convertible debt instruments that may be settled in cash upon conversion (including partial cash settlement) be separately accounted for in a manner that reflects an issuer’s non-convertible debt borrowing rate. The resulting debt discount is being amortized over the period the convertible debt is expected to be outstanding as non-cash interest expense.

The Company adopted FSP APB 14-1 effective January 1, 2009 and retroactive application to all periods presented is required. Upon adoption, the Company recorded a cumulative debt discount of $174,930 with an offsetting increase to stockholder’s equity (deficit). The debt discount is being amortized to interest expense over the term of the convertible notes, which resulted in a cumulative effect of a change in accounting principle of $36,214 being recorded as of January 1, 2007. In accordance with FSP APB 14-1, the Company is restating its 2007 and 2008 consolidated financial statements.

The Company’s net income for the three months ended March 31, 2009 of $129,813, or $0.96 per basic share and $0.85 per diluted share, includes amortization of the debt discount recorded upon adoption of FSP APB 14-1 of $6,398, or $0.05 per basic share and $0.04 per diluted share.

The table below sets forth the effect of the adoption of FSP APB 14-1 on the applicable line items within the consolidated statement of operations:


	Three months ended March 31, 2008
	As previously			Restatement
	reported			adjustments			Restated
Research and development expenses	$	72,554		$	137		$	72,691
Income (loss) from operations		(76,290	)		(137	)		(76,427	)
Interest expense		(9,851	)		(5,666	)		(15,517	)
Net income (loss)		(46,916	)		(5,803	)		(52,719	)

Basic and diluted net income (loss) per share	$	(0.35	)	$	(0.04	)	$	(0.39	)

HUMAN GENOME SCIENCES, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

For the Quarter Ended March 31, 2009

(dollars in thousands, except per share data)

Note 2. Adoption of FASB Staff Position No. APB 14-1 (“FSP APB 14-1”) (continued)

The table below sets forth the effect of the retroactive application of FSP APB 14-1 on the applicable line items within the consolidated balance sheet:


	As of December 31, 2008
	As previously			Restatement
	reported			adjustments			Restated
Property, plant and equipment (net of accumulated depreciation and amortization)	$	259,269		$	15,046		$	274,315
Other assets		9,123			(2,378	)		6,745
Convertible subordinated debt		510,000			(92,403	)		417,597
Additional paid-in capital		1,889,502			169,652			2,059,154
Accumulated deficit		(2,127,744	)		(64,581	)		(2,192,325	)

The increase in property, plant and equipment relates to increased capitalization of non-cash interest expense for the Company’s large-scale manufacturing facility arising from the impact of using the Company’s non-convertible debt borrowing rate on a retrospective basis.

The table below sets forth the effect of the retroactive application of FSP APB 14-1 on the applicable line items within the consolidated statement of cash flows:


	Three months ended March 31, 2008
	As previously			Restatement
	reported			adjustments			Restated
Net Income (loss)	$	(46,916	)	$	(5,803	)	$	(52,719	)
Depreciation and amortization		5,210			(51	)		5,159
Amortization of debt discount		—			5,854			5,854

HUMAN GENOME SCIENCES, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

For the Quarter Ended March 31, 2009

(dollars in thousands, except per share data)

Note 3. Comprehensive Income (Loss)

SFAS No. 130, Reporting Comprehensive Income, requires unrealized gains or losses on the Company’s available-for-sale short-term securities, marketable securities and long-term equity investments and cumulative foreign currency translation adjustment activity to be included in other comprehensive income.

During the three months ended March 31, 2009 and 2008, total comprehensive income (loss) amounted to:


	Three months ended March 31,
				2008
	2009			(Restated)
Net income (loss)	$	129,813		$	(52,719	)

Net unrealized gains (losses):
Short-term investments and marketable securities		345			1,751
Long-term equity investments in VIA Pharmaceuticals		—			122
Restricted investments		84			598
Foreign currency translation		547			19

Subtotal		976			2,490
Reclassification adjustments for (gains) losses realized in net loss		(887	)		(41	)

Total comprehensive income (loss)	$	129,902		$	(50,270	)

Realized gains and losses on securities sold before maturity, which are included in the Company’s investment income for the three months ended March 31, 2009 and 2008, and their respective net proceeds were as follows:


	Three months ended March 31,
	2009			2008
Net proceeds from sale of investments prior to maturity	$	91,003		$	35,309
Realized gains		1,633			128
Realized losses		(742	)		(88	)

Note 4. Collaboration Agreements, License Agreement and U.S. Government Agreement

Collaboration Agreement with Novartis

During 2006, the Company entered into an agreement with Novartis International Pharmaceutical Ltd. (“Novartis”) for the co-development and commercialization of Albuferon^®. Under the agreement, the Company and Novartis will co-commercialize Albuferon in the United States, and will share U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization outside the U.S. and will pay the Company a royalty on those sales. The Company will have primary responsibility for the bulk manufacture of Albuferon, and Novartis will have primary responsibility for commercial manufacturing of the finished drug product. The Company is entitled to payments aggregating approximately $507,500, including a non-refundable up-front license fee, upon the successful attainment of certain milestones. The Company and Novartis share clinical development costs. The Company received an up-front license fee of $45,000 in 2006. Including the up-front fee, as of March 31, 2009, the Company has contractually earned and received payments aggregating $132,500. The Company is recognizing these payments as revenue ratably over the estimated remaining development period, estimated to end in 2010. The Company recognized revenue of $8,852 for the three months ended March 31, 2009 and 2008.

HUMAN GENOME SCIENCES, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

For the Quarter Ended March 31, 2009

(dollars in thousands, except per share data)

Note 4. Collaboration Agreements, License Agreement and U.S. Government Agreement (continued)

Collaboration Agreement with GSK

During 2006, the Company entered into an agreement with GlaxoSmithKline (“GSK”) for the co-development and commercialization of LymphoStat-B^® arising from an option GSK exercised in 2005, relating to an earlier collaboration agreement. The agreement grants GSK a co-development and co-commercialization license, under which both companies will jointly conduct activities related to the development and sale of products in the United States and abroad. The Company and GSK will share in Phase 3 and 4 development costs, sales and marketing expenses and profits of any product commercialized under the agreement. The Company is conducting Phase 3 clinical trials and will have primary responsibility for bulk manufacturing. In partial consideration of the rights granted to GSK in this agreement, the Company received a non-refundable payment of $24,000 during 2006 and is recognizing this payment as revenue over the remaining clinical development period, estimated to end in 2010. The Company recognized revenue of $1,636 for the three months ended March 31, 2009 and 2008 relating to this payment.

Collaboration reimbursements

Research and development expenses for the three months ended March 31, 2009 and 2008 are net of $12,505 and $20,818, respectively, of costs reimbursed by Novartis and GSK.

Agreement with Teva Biopharmaceuticals USA, Inc. (formerly CoGenesys)

In 2008, Teva Pharmaceuticals Industries, Ltd. (“Teva”) acquired all the outstanding stock of CoGenesys and CoGenesys became a wholly-owned subsidiary of Teva called Teva Biopharmaceutical USA, Inc. (“Teva Bio”). The Company had sold its CoGenesys division in 2006 and entered into a license agreement, as amended, and a manufacturing services agreement, as amended, that are now with Teva Bio, and acquired an equity investment in CoGenesys valued at $14,818. The Company allocated, based on estimated fair values, $7,575 of its consideration received to the product license and manufacturing services agreements, which is being recognized ratably over the term of the manufacturing services agreement. The Company recognized revenue relating to these agreements of $631 and $910 during the three months ended March 31, 2009 and 2008, respectively.

As a result of Teva’s acquisition of CoGenesys, the Company received $47,336 as partial payment for its equity investment in CoGenesys during the three months ended March 31, 2008. The agreement between CoGenesys and Teva provided for an escrow of a portion of the purchase price. The Company received the final payment for its equity investment in CoGenesys during the three months ended March 31, 2009 and recorded a gain of $5,259.

U.S. Government Agreement

During 2006, the United States Government (“USG”) exercised its option under the second phase of a 2005 contract to purchase 20,001 therapeutic courses of ABthrax for its Strategic National Stockpile. Under this two-phase contract, the Company has supplied ABthrax, a human monoclonal antibody developed for use in the treatment of anthrax disease, to the USG. Under the first phase of the contract, the Company supplied ten grams of ABthrax to the U.S. Department of Health and Human Services (“HHS”) for comparative in vitro and in vivo testing. In 2006, the Company received and recognized $308 of revenue relating to the completion of testing of the evaluation material. Along with the cost to manufacture the 20,001 therapeutic courses, the Company has incurred substantially all of the cost to conduct several animal and human studies as part of this contract. During the three months ended March 31, 2009, the Company received authorization from BARDA to ship ABthrax to the U.S. Strategic National Stockpile and delivered substantially all of the 20,001 therapeutic courses. During the three months ended March 31, 2009, the Company recognized $127,769 in product revenue and $25,997 in manufacturing and development services revenue related to the work to conduct the animal and human studies. The Company expects to complete delivery under this contract during the second quarter of 2009 and recognize additional revenue from product sales and development services. The Company expects to receive an additional payment if the Company obtains licensure by FDA.

HUMAN GENOME SCIENCES, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

For the Quarter Ended March 31, 2009

(dollars in thousands, except per share data)

Note 4. Collaboration Agreements, License Agreement and U.S. Government Agreement (continued)

Costs to manufacture ABthrax were incurred prior to 2009, and were expensed as incurred. Cost of product sales for the three months ended March 31, 2009 represents royalty costs related to product sales.

Aegera Agreement

During 2007, the Company entered into a collaboration and license agreement with Aegera Therapeutics, Inc. (“Aegera”) of Montreal, Canada under which the Company acquired exclusive worldwide rights (excluding Japan) to develop and commercialize certain oncology molecules and related backup compounds to be chosen during a three-year research period. Under the agreement, the Company paid Aegera an aggregate of $20,000 for the license and for an equity investment in Aegera. The Company allocated $16,852 to the license fee and $3,148 to the investment. The value per share assigned to this investment was equal to the value per share obtained by Aegera through external financing earlier in 2007. Aegera will be entitled to receive up to $295,000 in future development and commercial milestone payments, including a $5,000 milestone payment made by the Company during the three months ended March 31, 2008. Aegera will receive royalties on net sales in the Company’s territory. In North America, Aegera will have the option to co-promote with the Company, under which Aegera will share certain expenses and profits in lieu of its royalties. The Company incurred and expensed costs of $587 and $561 related to the Aegera agreement during the three months ended March 31, 2009 and 2008, respectively.

Note 5. Accounts Receivable and Collaboration Receivables

Accounts receivable includes billed and unbilled amounts of $32,308 and $6,198, respectively, as of March 31, 2009. Over 90% of the aggregate balance of $38,506 at March 31, 2009 is due from the U.S. Government for ABthrax product and service revenue. Collaboration receivables of $12,885 includes $12,260 in unbilled receivables from Novartis and GSK in connection with the Company’s cost-sharing agreements, and other unbilled receivables. The $12,885 in unbilled receivables relates to net cost reimbursements due for the three months ended March 31, 2009.

HUMAN GENOME SCIENCES, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

For the Quarter Ended March 31, 2009

(dollars in thousands, except per share data)

Note 6. Long-Term Debt

As discussed in Note 2, Adoption of FASB Staff Position No. APB 14-1 (“FSP APB 14-1”), FSP APB 14-1 impacted the carrying value of the Company’s 2¹/4% Convertible Subordinated Notes due October 2011 (“2¹/4% Notes due 2011”) and 2¹/4% Convertible Subordinated Notes due 2012 (“2¹/4% Notes due 2012”) for all periods presented. As a result of the adoption of FSP APB 14-1, the Company is amortizing the debt discount of $174,930 over the term of the notes.

During the three months ended March 31, 2009, the Company repurchased 2¹/4% Notes due 2011 with a face value of $82,900 and 2¹/4% Notes due 2012 with a face value of $23,250 for an aggregate cost of approximately $50,000 plus accrued interest. The repurchase resulted in a gain on extinguishment of debt of $38,873, net of the related debt discount of $16,424 and deferred financing charges of $855.

The components of Convertible subordinated debt are as follows:


	March 31, 2009
			Unamortized
Debt	Face Value		Debt Discount			Carrying Value
2¹/4% Notes due 2011	$	197,100	$	(26,154	)	$	170,946
2¹/4% Notes due 2012		206,750		(43,427	)		163,323

	$	403,850	$	(69,581	)	$	334,269


	December 31, 2008
			Unamortized
	Face Value		Debt Discount			Carrying Value
2¹/4% Notes due 2011	$	280,000	$	(40,753	)	$	239,247
2¹/4% Notes due 2012		230,000		(51,650	)		178,350

	$	510,000	$	(92,403	)	$	417,597

Note 7. Commitments and Other Matters

The Company is party to various claims and legal proceedings from time to time. The Company is not aware of any legal proceedings that it believes could have, individually or in the aggregate, a material adverse effect on its results of operations, financial condition or liquidity.

Note 8. Facility-Related Exit Costs

As a result of the Company’s facilities consolidation efforts, the Company has exited various facility leases since 2004 and recorded exit and impairment charges relating to those exits. During 2006, the Company exited certain of its headquarters space and in 2007, the Company entered into an agreement to sublease a portion of this space. Subsequent to March 31, 2009, the subtenant delivered notice of early termination to the Company and will vacate the space later in 2009. The subtenant has paid an early termination fee which represents rent through December 2009. The Company has begun the search for a new subtenant. The Company reviews the adequacy of its estimated exit accrual on an ongoing basis, and may need to adjust its exit accrual as a result of the termination of the sublease.

HUMAN GENOME SCIENCES, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

For the Quarter Ended March 31, 2009

(dollars in thousands, except per share data)

Note 8. Facility-Related Exit Costs (continued)

The following table summarizes the activity related to the liability for exit charges for the three months ended March 31, 2009, all of which is facilities-related:


Balance as of December 31, 2008	$	5,027
Accretion recorded		152

Subtotal		5,179
Cash paid		(1,323	)

Balance as of March 31, 2009		3,856
Less current portion		(2,025	)

	$	1,831

Note 9. Stock-Based Compensation

The Company has a stock incentive plan (the “Incentive Plan”) under which options to purchase new shares of the Company’s common stock may be granted to employees, consultants and directors at an exercise price no less than the quoted market value on the date of grant. The Incentive Plan also provides for awards in the form of stock appreciation rights, restricted (nonvested) or unrestricted stock awards, stock-equivalent units or performance-based stock awards. The Company issues both qualified and non-qualified options under the Incentive Plan. The Company also has an Employee Stock Purchase Plan (the “Purchase Plan”).

Stock-based compensation expense related to employee stock options under SFAS No. 123(R), Share-Based Payment (“SFAS No. 123(R)”), for the three months ended March 31, 2009 is not necessarily representative of the level of stock-based compensation expense under SFAS No. 123(R) in future periods due to, among other things, (1) the vesting period of the stock options and (2) the fair value of additional stock option grants in future years.

The Company recorded stock-based compensation expense pursuant to these plans of $2,935 and $4,463 during the three months ended March 31, 2009 and 2008, respectively. Stock-based compensation relates to stock options, restricted stock units and restricted stock awards granted under the Incentive Plan and stock acquired by employees through the Purchase Plan.

Under the Incentive Plan, the Company issued no shares of common stock in conjunction with stock option exercises during the three months ended March 31, 2009. The Company granted 3,692,303 stock options under the Incentive Plan during the same period, with a weighted-average grant date fair value of $0.31 per share.

During the three months ended March 31, 2009, the Company awarded 65,587 restricted stock units (“RSUs”) with a weighted-average grant date fair value of $0.52 per share. During the same period, 73,066 RSUs vested and the Company issued 44,344 shares of common stock to employees, net of 28,722 shares purchased to satisfy the employees’ tax liability related to the RSUs vesting. This treasury stock was retired prior to March 31, 2009.

At March 31, 2009, the total authorized number of shares under the Incentive Plan, including prior plans, was 53,278,056. Options available for future grant were 4,051,913 as of March 31, 2009.

HUMAN GENOME SCIENCES, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

For the Quarter Ended March 31, 2009

(dollars in thousands, except per share data)

Note 10. Fair Value of Financial Instruments

The Company has adopted SFAS No. 157 for all assets and liabilities. This standard defines fair value, provides guidance for measuring fair value and requires certain disclosures. This standard does not require any new fair value measurements, but rather applies to all other accounting pronouncements that require or permit fair value measurements. This standard does not apply to measurements related to share-based payments.

SFAS No. 157 discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the service capacity of an asset or replacement cost). The statement utilizes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The following is a brief description of those three levels:

	Level 1:		Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities.

	Level 2:		Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.

	Level 3:		Unobservable inputs that reflect the reporting entity’s own assumptions.

Active markets are those in which transactions occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Inactive markets are those in which there are few transactions for the asset, prices are not current, or price quotations vary substantially either over time or among market makers, or in which little information is released publicly. With regard to the Company’s financial assets subject to fair value measurements, the Company believes that all of the assets it holds are actively traded because there is sufficient frequency and volume to obtain pricing information on an ongoing basis.

The Company’s assets and liabilities subject to fair value measurements and the related fair value hierarchy are as follows:


	Fair Value		Fair Value Measurements at March 31, 2009
	as of		Using Fair Value Hierarchy
Description	March 31, 2009		Level 1		Level 2		Level 3
Cash and cash equivalents	$	93,094	$	93,094	$	—	$	—
Short-term investments		97,979		—		97,979		—
Marketable securities		138,210		7,762		130,448		—
Restricted investments		67,569		6,717		60,852		—

Total	$	396,852	$	107,573	$	289,279	$	—

The Company evaluates the types of securities in its investment portfolios to determine the proper classification in the fair value hierarchy based on trading activity and the observability of market inputs. The Company’s Level 1 assets include cash, money market instruments and U.S. Treasury securities. Level 2 assets include government-sponsored enterprise securities, commercial paper, corporate bonds, asset-backed securities, and mortgage-backed securities. The Company’s privately-held equity investment is carried at cost and is not included in the table above, and is reviewed for impairment at each reporting date.

HUMAN GENOME SCIENCES, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

For the Quarter Ended March 31, 2009

(dollars in thousands, except per share data)

Note 10. Fair Value of Financial Instruments (continued)

The Company generally obtains a single quote or price per instrument from independent third parties to help it determine the fair value of securities in Level 1 and Level 2 of the fair value hierarchy. The Company’s Level 1 cash and money market instruments are valued based on quoted prices from third parties, and the Company’s Level 1 U.S. Treasury securities are valued based on broker quotes. The Company’s Level 2 assets are valued using a multi-dimensional pricing model that includes a variety of inputs including actual trade data, benchmark yield data, non-binding broker/dealer quotes, issuer spread data, monthly payment information, collateral performance and other reference information. These are all observable inputs. The Company reviews the values generated by the multi-dimensional pricing model for reasonableness, which could include reviewing other publicly available information.

The Company does not hold auction rate securities, loans held for sale, mortgage-backed securities backed by sub-prime or Alt-A collateral or any other investments which require the Company to determine fair value using a discounted cash flow approach. Therefore, the Company does not need to adjust its analysis or change its assumptions specifically to factor illiquidity in the markets into its fair values.

Note 11. Earnings Per Share

Basic net income (loss) per share is computed based on the weighted average number of common shares outstanding during the period. Diluted net income (loss) per share is computed based on the weighted average number of common shares outstanding and, if there is net income during the period, the dilutive impact of common stock equivalents outstanding during the period. Common stock equivalents result from the assumed exercise of outstanding stock options, the assumed conversion of convertible subordinated debt and the vesting of unvested restricted stock units. Common stock equivalents that were not included in the calculation of diluted shares for the three months ended March 31, 2009 and 2008, because the effect would have been anti-dilutive, were 28,739,363 and 62,334,091, respectively.

Diluted net income (loss) per share was determined as follows:


	Three months ended March 31,
	2009		2008 (Restated)
Numerator:
Net income (loss)	$	129,813	$	(52,719	)
Interest on convertible subordinated debt, if converted		9,249		—

Net income used for diluted net income (loss) per share	$	139,062	$	(52,719	)


Denominator:
Weighted average shares outstanding		135,755,471		135,284,778
Effect of dilutive securities:
Convertible subordinated debt		27,375,405		—
Employee stock options and restricted stock units		292,611		—

Weighted average shares used for diluted net income (loss) per share		163,423,487		135,284,778


Diluted net income (loss) per share	$	0.85	$	(0.39	)

Note 12. Reclassifications

Within the December 31, 2008 consolidated balance sheet, $2,804 has been reclassified from collaboration receivables to accounts receivable and $67 has been reclassified from prepaid and other assets to accounts receivable, respectively, to conform to current year presentation. The effect of the reclassifications is not material to the consolidated financial statements.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Three months ended March 31, 2009 and 2008

Overview

Human Genome Sciences, Inc. (“HGS”) is a commercially focused biopharmaceutical company. In January 2009, we achieved our first product sales when we began delivery of ABthrax to the U.S. Strategic National Stockpile. We have two other products in late-stage clinical development: Albuferon^® for chronic hepatitis C and LymphoStat-B^® for systemic lupus erythematosus (“SLE”).

Albuferon and LymphoStat-B are progressing toward commercialization. In December 2008 and March 2009, we reported that Albuferon successfully met its primary endpoint in two Phase 3 clinical trials in chronic hepatitis C. We expect the filing of global marketing applications for Albuferon in fall 2009. We completed enrollment in both Phase 3 trials of LymphoStat-B in SLE in 2008, and we expect to report the results of these studies in July and November 2009. Assuming success in Phase 3, we plan to file global marketing applications for LymphoStat-B in the first half of 2010.

We also have substantial financial rights to two novel drugs that GlaxoSmithKline (“GSK”) has advanced to late-stage development. In December 2008, GSK initiated the first Phase 3 clinical trial of darapladib, which was discovered by GSK based on HGS technology, in more than 15,000 men and women with chronic coronary heart disease. GSK plans to initiate a second large Phase 3 trial of darapladib in late 2009. In February 2009, GSK initiated a Phase 3 clinical trial program for Syncria^® (albiglutide) in the long-term treatment of type 2 diabetes mellitus. Syncria was created by HGS using our proprietary albumin-fusion technology, and we licensed Syncria to GSK in 2004.

HGS also has several novel drugs in earlier stages of clinical development for the treatment of cancer, led by our TRAIL receptor antibody HGS-ETR1 and a small-molecule antagonist of IAP (inhibitor of apoptosis) proteins.

Our strategic partnerships with leading pharmaceutical and biotechnology companies allow us to leverage our strengths and gain access to sales and marketing infrastructure, as well as complementary technologies. Some of these partnerships provide us with licensing or other fees, clinical development cost-sharing, milestone payments and rights to royalty payments as products are developed and commercialized. In some cases, we are entitled to certain commercialization, co-promotion, revenue-sharing and other product rights.

During the three months ended March 31, 2009, we achieved our first product sales when we began delivery of ABthrax to the U.S. Strategic National Stockpile. Any significant revenue from other product sales or from royalties on product sales in the next several years is uncertain.

During 2006, we entered into a collaboration agreement with Novartis International Pharmaceutical, Ltd. (“Novartis”). Under this agreement, Novartis will co-develop and co-commercialize Albuferon and share development costs, sales and marketing expenses and profits of any product that is commercialized in the U.S. Novartis will be responsible for commercialization outside the U.S. and will pay HGS a royalty on these sales. We received a $45.0 million up-front fee from Novartis upon the execution of the agreement. Including this up-front fee, we are entitled to payments aggregating $507.5 million upon the successful attainment of certain milestones. As of March 31, 2009, we have contractually earned and received payments aggregating $132.5 million. We are recognizing these payments as revenue ratably over the estimated remaining development period, estimated to end in 2010.

In 2005, GSK exercised its option to co-develop and co-commercialize LymphoStat-B. In accordance with a co-development and co-commercialization agreement signed during 2006 we and GSK will share Phase 3 and 4 development costs, and will share equally in sales and marketing expenses and profits of any product that is commercialized. We received a $24.0 million payment during 2006 as partial consideration for entering into this agreement with respect to LymphoStat-B and are recognizing this payment as revenue ratably over the development period, estimated to end in 2010.

Overview (continued)

In 2005, we entered into a two-phase contract to supply ABthrax, a human monoclonal antibody developed for use in the treatment of anthrax disease, with the U.S. Government. Under the first phase of the contract, we supplied ten grams of ABthrax to the U.S. Department of Health and Human Services (“HHS”) for comparative in vitro and in vivo testing. During 2006, under the second phase of the contract, the U.S. Government exercised its option to purchase 20,001 treatment courses of ABthrax for the Strategic National Stockpile. In January 2009, we began delivery of ABthrax to the U.S. Strategic National Stockpile, and in February 2009 the product was accepted and we recorded revenue of $127.8 million for the product as well as service revenue of $26.0 million for other work done to develop ABthrax.

We expect that any significant revenue or income through at least 2010 may be limited to ABthrax revenue, payments under collaboration agreements (to the extent milestones are met), cost reimbursements from GSK and Novartis, payments from the license of product rights, payments under manufacturing agreements, such as our agreement with Hospira, Inc., investment income and other payments from other collaborators and licensees under existing or future arrangements, to the extent that we enter into any future arrangements. We expect our ABthrax product sales under the current contract for the remainder of 2009 to be approximately $8.6 million. We expect to continue to incur substantial expenses relating to our research and development efforts. As a result, we expect to incur significant losses over the next several years unless we are able to realize additional revenues under existing or any future agreements. The timing and amounts of such revenues, if any, cannot be predicted with certainty and will likely fluctuate sharply. Results of operations for any period may be unrelated to the results of operations for any other period. In addition, historical results should not be viewed as indicative of future operating results.

We adopted Financial Accounting Standards Board (“FASB”) Staff Position No. APB 14-1, Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement) (“FSP APB 14-1”) effective January 1, 2009. FSP APB 14-1 requires retroactive application to all periods presented; therefore, we have restated our consolidated statement of operations and statement of cash flows contained in our Form 10-Q for the period ended March 31, 2008 and we have also restated our consolidated balance sheet contained in our 2008 Annual Report on Form 10-K. See Note 2, Adoption of FASB Staff Position No. APB 14-1 (“FSP APB 14-1”), of the Notes to the Consolidated Financial Statements for additional information. The effects of the restatement on the consolidated financial statements are reflected in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” below.

Critical Accounting Policies and the Use of Estimates

A “critical accounting policy” is one that is both important to the portrayal of our financial condition and results of operations and that requires management’s most difficult, subjective or complex judgments. Such judgments are often the result of a need to make estimates about the effect of matters that are inherently uncertain. The preparation of our financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from those estimates. Our accounting policies are described in more detail in Note B, Summary of Significant Accounting Policies, to our consolidated financial statements included in our 2008 Annual Report on Form 10-K. The following is an update to those critical accounting policies for new activity in 2009:

Product sales

Manufacturing and development services

Results of Operations

Revenues. Revenues were $177.3 million for the three months ended March 31, 2009 compared to revenues of $12.3 million for the three months ended March 31, 2008. Revenues for the three months ended March 31, 2009 included $127.8 million in ABthrax product sales and $26.0 million related to certain ABthrax development services, as well as a $9.0 million milestone payment received from GSK related to Syncria. Revenues for the three months ended March 31, 2009 and 2008 also included $8.9 million recognized from the Novartis agreement and $1.6 million recognized from the GSK LymphoStat-B agreement.

Cost of sales. Cost of sales represents cost of product sales of $8.2 million and cost of manufacturing and development services of $3.4 million for the three months ended March 31, 2009. With respect to ABthrax, we incurred substantially all of the product and service costs prior to 2009, and expensed these costs as incurred. We have incurred royalty costs in 2009, which are included in cost of product sales. Our manufacturing and development service costs include ABthrax development service costs incurred in 2009 and costs associated with contract manufacturing services. There were no comparable costs in 2008 as we had no revenue from product sales or manufacturing and development services. After marketing approval of a product, cost of product sales will include the various costs to manufacture the product, including raw materials, labor and overhead.

Expenses. Research and development net expenses were $53.7 million for the three months ended March 31, 2009 compared to $72.7 million for the three months ended March 31, 2008. Our research and development expenses for the three months ended March 31, 2009 and 2008 are net of $12.5 million and $20.8 million, respectively, of costs reimbursed by Novartis and GSK.

We track our research and development expenditures by type of cost incurred – research, pharmaceutical sciences, manufacturing and clinical development.

Our research costs decreased to $5.0 million for the three months ended March 31, 2009 from $10.1 million for the three months ended March 31, 2008. This decrease is primarily due to a $5.0 million milestone payment made to Aegera Therapeutics, Inc. (“Aegera”) in 2008. Our research costs for the three months ended March 31, 2009 and 2008 are net of $0.7 million and $0.9 million, respectively, of cost reimbursement from Novartis and GSK under cost sharing provisions in our collaboration agreements.

Our pharmaceutical sciences costs, where we focus on improving formulation, process development and production methods, decreased to $8.1 million for the three months ended March 31, 2009 from $9.6 million for the three months ended March 31, 2008. This decrease is primarily due to decreased activity related to ABthrax and Albuferon, partially offset by increased new target development. Pharmaceutical sciences costs for the three months ended March 31, 2009 and 2008 are net of $0.2 million and $0.4 million, respectively, of cost reimbursement from Novartis and GSK under cost sharing provisions in our collaboration agreements.

Our manufacturing costs decreased to $19.7 million for the three months ended March 31, 2009 from $22.9 million for the three months ended March 31, 2008. This decrease is primarily due to decreased production of HGS-ETR1 and Albuferon, partially offset by new manufacturing services activities. Our manufacturing costs for the three months ended March 31, 2009 and 2008 are net of $0.2 million and $2.4 million, respectively, of cost reimbursement from Novartis and GSK under cost sharing provisions in our collaboration agreements. Our cost reimbursements for manufacturing for the remainder of 2009 may vary from quarter to quarter depending on collaboration-related manufacturing activity.

Our clinical development costs decreased to $20.9 million for the three months ended March 31, 2009 from $30.1 million for the three months ended March 31, 2008. The decrease is primarily due to the substantial completion of our Albuferon Phase 3 clinical trials in late 2008 and reduced costs for HGS-ETR1. Our clinical development expenses for the three months ended March 31, 2009 and 2008 are net of $11.4 million and $17.1 million, respectively, of cost reimbursement from Novartis and GSK under cost sharing provisions in our collaboration agreements.

General and administrative expenses decreased to $14.3 million for the three months ended March 31, 2009 compared to $16.0 million for the three months ended March 31, 2008. This decrease is primarily due to decreased legal expenses associated with our patents.

Results of Operations (continued)

Investment income decreased to $4.3 million for the three months ended March 31, 2009 from $6.7 million for the three months ended March 31, 2008. The decrease in investment income for the three months ended March 31, 2009 was primarily due to lower average investment balances and also lower yields on our portfolio.

Interest expense increased to $15.7 million for the three months ended March 31, 2009 compared to $15.5 million for the three months ended March 31, 2008. Interest expense includes non-cash interest expense related to amortization of debt discount of $6.4 million and $5.9 million for the three months ended March 31, 2009 and 2008, respectively, as a result of the adoption of FSP APB 14-1.

The gain on extinguishment of debt of $38.9 million for the three months ended March 31, 2009 relates to the repurchase of convertible subordinated debt due in 2011 and 2012 with a face value of approximately $106.2 million for an aggregate cost of approximately $50.0 million plus accrued interest. The gain on extinguishment of debt is net of write-offs of related debt discount of $16.4 million and deferred financing charges of $0.9 million.

Our gain on sale of long-term equity investment during the three months ended March 31, 2009 and 2008 of $5.3 million and $32.5 million, respectively, relates to the 2008 sale of our investment in CoGenesys. We received initial proceeds in February 2008 of $47.3 million. Our cost basis in this investment was $14.8 million, resulting in a gain of $32.5 million. The agreement between CoGenesys and Teva provided for an escrow of a portion of the purchase price. We received the final payment for our equity investment in CoGenesys during the three months ended March 31, 2009, and recorded an additional gain of $5.3 million.

Other expense of $0.7 million represents unrealized, non-cash foreign currency translation losses, related to our investment in Aegera, which is denominated in Canadian dollars.

Net Income (Loss). We recorded net income of $129.8 million, or $0.96 per basic share and $0.85 per diluted share, for the three months ended March 31, 2009 compared to a net loss of $52.7 million, or $0.39 per basic and diluted share, for the three months ended March 31, 2008. The increase is primarily due to revenue from ABthrax, gain on extinguishment of debt, revenue related to a collaboration milestone for Syncria and reduced expenses.

Liquidity and Capital Resources

We had working capital of $118.1 million at March 31, 2009 as compared to a working capital shortfall of $52.5 million at December 31, 2008. The increase in our working capital is primarily due to the cash or receivables provided by our ABthrax revenue of $153.8 million, net of $50.0 million used in February 2009 to extinguish approximately $106.2 million of our convertible subordinated debt.

We expect to continue to incur substantial expenses relating to our research and development efforts as we focus on clinical trials and manufacturing required for the development of our active product candidates. We will also incur costs related to our pre-commercial launch activities. In the event our working capital needs for 2009 exceed our available working capital, we can utilize our non-current marketable securities, which are classified as “available-for-sale”. Our working capital position may decline during the remainder of 2009 as we expect significantly less ABthrax revenue than the $153.8 million recognized during the three months ended March 31, 2009. However, we may receive payments under collaboration agreements, to the extent milestones are met, which would improve our working capital position. We will be evaluating our working capital position on a continuing basis.

To minimize our exposure to credit risk, we invest in securities with strong credit ratings and have established guidelines relative to diversification and maturity with the objectives of maintaining safety of principal and liquidity. We do not invest in derivative financial instruments or auction rate securities, and we generally hold our investments in debt securities until maturity. However, the deterioration of the credit markets during 2008 had a detrimental effect on our investment portfolio. At March 31, 2009, we have gross unrealized losses on our available-for-sale investments of approximately $9.5 million. Our unrealized losses substantially relate to corporate debt securities. Our other non-current marketable securities, consisting primarily of government-sponsored enterprise securities, have not experienced any significant unrealized losses at March 31, 2009. The amortized cost and fair value of these other non-current marketable securities are approximately $58.0 million and $59.7 million, respectively, at March 31, 2009. If needed, we could liquidate some or all of these securities in order to meet our working capital needs.

Liquidity and Capital Resources (continued)

The amounts of expenditures that will be needed to carry out our business plan are subject to numerous uncertainties, which may adversely affect our liquidity and capital resources. We are conducting two Phase 3 trials and have several ongoing Phase 1 and Phase 2 trials and expect to initiate additional trials in the future. Completion of these trials may extend several years or more, but the length of time generally varies considerably according to the type, complexity, novelty and intended use of the drug candidate. We estimate that the completion periods for our Phase 1, Phase 2, and Phase 3 trials could span one year, one to two years and two to four years, respectively. Some trials may take considerably longer to complete. The duration and cost of our clinical trials are a function of numerous factors such as the number of patients to be enrolled in the trial, the amount of time it takes to enroll them, the length of time they must be treated and observed, and the number of clinical sites and countries for the trial.

Our clinical development expenses are impacted by the clinical phase of our drug candidates. Our expenses increase as our drug candidates move to later phases of clinical development. The status of our clinical projects is as follows:


		Clinical Trial Status as of March 31, ⁽²⁾
Product Candidate ⁽¹⁾	Indication	2009			2008
Albuferon	Hepatitis C	Phase 3⁽³⁾			Phase 3
LymphoStat-B	Systemic Lupus Erythematosus	Phase 3			Phase 3
LymphoStat-B	Rheumatoid Arthritis	Phase 2⁽⁴⁾			Phase 2⁽⁴⁾
HGS-ETR1	Cancer	Phase 2			Phase 2
HGS-ETR2	Cancer	Phase 1			Phase 1
ABthrax	Anthrax		(5	)		(5	)
HGS1029	Cancer	Phase 1				(6	)


(1)		Includes only those candidates for which an Investigational New Drug (“IND”) application has been filed with the FDA.

(2)		Clinical Trial Status defined as when patients are being dosed.

(3)		Patient dosing completed during 2008 and Phase 3 results reported; pre-BLA (Biologics License Application) activities underway; Phase 2 monthly dosing study underway.

(4)		Initial Phase 2 trial completed; extension safety study ongoing and further development under review.

(5)		We have delivered substantially all of the 20,001 doses of ABthrax to the U.S. Strategic National Stockpile. Pre-BLA activities underway; we anticipate filing a BLA in the second quarter of 2009.

(6)		IND filed in December 2007 with respect to HGS1029 (formerly AEG40826).

We identify our drug candidates by conducting numerous preclinical studies. We may conduct multiple clinical trials to cover a variety of indications for each drug candidate. Based upon the results from our trials, we may elect to discontinue clinical trials for certain indications or certain drugs in order to concentrate our resources on more promising drug candidates.

We are advancing a number of drug candidates, including antibodies, an albumin fusion protein and a small molecule, in part to diversify the risks associated with our research and development spending. In addition, our manufacturing plants have been designed to enable multi-product manufacturing capability. Accordingly, we believe our future financial commitments, including those for preclinical, clinical or manufacturing activities, are not substantially dependent on any single drug candidate. Should we be unable to sustain a multi-product drug pipeline, our dependence on the success of a single drug candidate would increase.

Liquidity and Capital Resources (continued)

We must receive regulatory clearance to advance each of our products into and through each phase of clinical testing. Moreover, we must receive regulatory approval to launch any of our products commercially. In order to receive such approval, the appropriate regulatory agency must conclude that our clinical data establish safety and efficacy and that our products and the manufacturing facilities meet all applicable regulatory requirements. We cannot be certain that we will establish sufficient safety and efficacy data to receive regulatory approval for any of our drugs or that our drugs and the manufacturing facilities will meet all applicable regulatory requirements.

Part of our business plan includes collaborating with others. For example, we entered into a collaboration agreement in 2006 with Novartis to co-develop and co-commercialize Albuferon. Under this agreement, we will co-commercialize Albuferon in the United States, and will share U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization outside the U.S. and will pay us a royalty on those sales. We and Novartis share clinical development costs. Including a non-refundable up-front license fee, we are entitled to payments aggregating approximately $507.5 million upon successful attainment of certain milestones. As of March 31, 2009, we have contractually earned and received milestones aggregating $132.5 million, including the up-front fee. In 2006, we entered into a collaboration agreement with GSK with respect to LymphoStat-B and received a payment of $24.0 million. We and GSK share Phase 3 and 4 development costs, and will share equally in sales and marketing expenses and profits of any product that is commercialized. During the three months ended March 31, 2009, we recorded approximately $12.5 million of reimbursable expenses from Novartis and GSK with respect to our cost sharing agreements as a reduction of research and development expenses. We are recognizing the up-front fees and milestones received from Novartis and GSK as revenue ratably over the estimated remaining development periods.

We have other collaborators who have sole responsibility for product development. For example, GSK is developing other products under separate agreements as part of our overall relationship with them. We have no control over the progress of GSK’s development plans. We cannot forecast with any degree of certainty whether any of our current or future collaborations will affect our drug development.

Because of the uncertainties discussed above, the costs to advance our research and development projects are difficult to estimate and may vary significantly. We expect that our existing funds, payments to be received under the ABthrax contract and other agreements and investment income will be sufficient to fund our operations for at least the next twelve months.

Our future capital requirements and the adequacy of our available funds will depend on many factors, primarily including the scope and costs of our clinical development programs, the scope and costs of our manufacturing and process development activities, the magnitude of our discovery and preclinical development programs and the level of our pre-commercial launch activities. There can be no assurance that any additional financing required in the future will be available on acceptable terms, if at all.

Depending upon market and interest rate conditions, we explore, and, from time to time, may take actions to strengthen further our financial position. We may undertake financings and may repurchase or restructure some or all of our outstanding convertible debt instruments in the future depending upon market and other conditions. In February 2009 we repurchased approximately $106.2 million in face value of our convertible subordinated debt due in 2011 and 2012 at a cost of approximately $50.0 million plus accrued interest.

We have certain contractual obligations which may have a future effect on our financial condition, changes in financial condition, results of operations, liquidity, capital expenditures or capital resources that are material to investors. Our operating leases, along with our unconditional purchase obligations, are not recorded on our balance sheets. Debt associated with the sale and accompanying leaseback of our LSM facility to BioMed in 2006 is recorded on our balance sheet as of March 31, 2009 and December 31, 2008. Under the LSM lease, we have an option to purchase the property between 2009 and 2010 at prices ranging between approximately $254.9 million and $269.5 million, depending upon when we exercise this option. We have an option to purchase the Traville facility in 2016 for $303.0 million.

Our unrestricted and restricted funds may be invested in U.S. Treasury securities, government agency obligations, high grade corporate debt securities and various money market instruments rated “A-” or better. Such investments reflect our policy regarding the investment of liquid assets, which is to seek a reasonable rate of return consistent with an emphasis on safety, liquidity and preservation of capital.

Off-Balance Sheet Arrangements

During 1997 and 1999, we entered into two long-term leases with the Maryland Economic Development Corporation (“MEDCO”) expiring January 1, 2019 for a process development and small-scale manufacturing facility aggregating 127,000 square feet and built to our specifications. We have accounted for these leases as operating leases. The facility was financed primarily through a combination of bonds issued by MEDCO (“MEDCO Bonds”) and loans issued to MEDCO by certain State of Maryland agencies. We have no equity interest in MEDCO.

Rent is based upon MEDCO’s debt service obligations and annual base rent under the leases currently is approximately $3.8 million. The MEDCO Bonds are secured by letters of credit issued for the account of MEDCO which expire in December 2009. MEDCO’s debt service obligations may be affected by prevailing interest rate and credit conditions in 2009, which could in turn affect our rent and the level of our restricted investments. We have restricted investments of approximately $15.9 million and $15.7 million as of March 31, 2009 and December 31, 2008, respectively, and are required to maintain restricted investments of $15.0 million which serve as additional security for the MEDCO letters of credit reimbursement obligation. Upon default or early lease termination or in the event the letters of credit will not be renewed, the MEDCO Bond indenture trustee can draw upon the letters of credit to pay the MEDCO Bonds as they are tendered. In such an event, we could lose part or all of our restricted investments and could record a charge to earnings for a corresponding amount. Alternatively, we have an option during or at the end of the lease term to purchase this facility for an aggregate amount that declines from approximately $38.0 million in 2009 to approximately $21.0 million in 2019.

The lease agreements contain covenants with respect to tangible net worth, cash and cash equivalents and investment securities, restrictions on dividends, as well as other covenants.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995

Certain statements contained in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on our current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of our unproven business model, our dependence on new technologies, the uncertainty and timing of clinical trials, our ability to develop and commercialize products, our dependence on collaborators for services and revenue, our substantial indebtedness and lease obligations, our changing requirements and costs associated with facilities, intense competition, the uncertainty of patent and intellectual property protection, our dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in this filing and our other filings with the Securities and Exchange Commission. In addition, while we have begun shipment of ABthrax to the U.S. Strategic National Stockpile, we continue to face risks related to acceptance of future shipments and FDA’s approval of our Biologics License Application for ABthrax, if and when it is submitted. If we are unable to meet requirements associated with the ABthrax contract, future revenues from the sale of ABthrax to the U.S. Government will not occur. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We undertake no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

We do not have operations of a material nature that are subject to risks of foreign currency fluctuations. We do, however, have certain aspects of our global clinical studies that are subject to risks of foreign currency fluctuations. We do not use derivative financial instruments in our operations or investment portfolio. Our investment portfolio may be comprised of U.S. Treasuries, government-sponsored enterprise securities, high-grade debt having at least an “A-” rating at time of purchase and various money market instruments. The short-term nature of these securities, which currently have an average term of approximately 9 months, decreases the risk of a material loss caused by a market change related to interest rates.

We believe that a hypothetical 100 basis point adverse move (increase) in interest rates along the entire interest rate yield curve would adversely affect the fair value of our cash, cash equivalents, short-term investments, marketable securities and restricted investments by approximately $2.8 million, or approximately 0.7% of the aggregate fair value of $396.9 million, at March 31, 2009. For these reasons, and because these securities are generally held to maturity, we believe we do not have significant exposure to market risks associated with changes in interest rates related to our debt securities held as of March 31, 2009. We believe that any interest rate change related to our investment securities held as of March 31, 2009 is not material to our consolidated financial statements. As of March 31, 2009, the yield on comparable one-year investments was approximately 0.5%, as compared to our current portfolio yield of approximately 2.7%. However, given the short-term nature of these securities, the general decline in interest rates will adversely affect the interest earned from our portfolio as securities mature and are replaced with securities having a lower interest rate.

To minimize our exposure to credit risk, we invest in securities with strong credit ratings and have established guidelines relative to diversification and maturity with the objectives of maintaining safety of principal and liquidity. We do not invest in derivative financial instruments, auction rate securities, loans held for sale or mortgage-backed securities backed by sub-prime or Alt-A collateral, and we generally hold our investments in debt securities until maturity. However, adverse changes in the credit markets relating to credit risks would adversely affect the fair value of our cash, cash equivalents, marketable securities and restricted investments. During the three months ended March 31, 2009, the gross unrealized losses in our portfolio decreased from $9.9 million to $9.5 million. The majority of these unrealized losses related to our holdings of corporate debt securities. At March 31, 2009, the fair value of our corporate debt securities was approximately $157.8 million, or 52% of our total investment portfolio of $303.8 million. The remaining securities in our portfolio are either U.S. Treasury and agency securities or government-sponsored enterprise securities, which we believe are subject to less credit risk. In the event there is further deterioration in the credit market, the fair value of our corporate debt securities could further decline.

We have an equity investment in Aegera, which is a privately-held entity. We are unable to obtain a quoted market price with respect to the fair value of this investment. Our investment in Aegera is denominated in Canadian dollars and is subject to foreign currency risk. The carrying value is adjusted at each reporting date based on current exchange rates, and was $2.5 million at March 31, 2009. We review the carrying value of the Aegera investment on a periodic basis for indicators of impairment, and adjust the value accordingly.

The facility leases we entered into during 2006 require us to maintain minimum level of restricted investments of approximately $46.0 million, or $39.5 million if in the form of cash, as collateral for these facilities. Together with the requirement to maintain up to approximately $15.0 million in restricted investments with respect to our process development and manufacturing facility leases, and our additional collateral for one of our operating leases, our overall level of restricted investments is currently required to be approximately $64.5 million. Although the market value for these investments may rise or fall as a result of changes in interest rates, we will be required to maintain this level of restricted investments in either a rising or declining interest rate environment.

Our convertible subordinated notes bear interest at fixed rates. As a result, our interest expense on these notes is not affected by changes in interest rates.

Item 3. Quantitative and Qualitative Disclosures About Market Risk (continued)

During 2002, we established a wholly-owned subsidiary, Human Genome Sciences Europe GmbH (“HGS Europe”) that is assisting in our clinical trials and clinical research collaborations in European countries. Although HGS Europe’s activities are denominated primarily in euros, we believe the foreign currency fluctuation risks to be immaterial to our operations as a whole. During 2005, we established a wholly-owned subsidiary, Human Genome Sciences Pacific Pty Ltd. (“HGS Pacific”) that is sponsoring some of our clinical trials in the Asia/Pacific region. We currently do not anticipate HGS Pacific to have any operational activity and therefore we do not believe we will have any foreign currency fluctuation risks with respect to HGS Pacific.

Item 4. Controls and Procedures

Disclosure Controls and Procedures

Our management, including our principal executive and principal financial officers, has evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2009. Our disclosure controls and procedures are designed to provide reasonable assurance that the information required to be disclosed in this Quarterly Report on Form 10-Q has been appropriately recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive and principal financial officers, to allow timely decisions regarding required disclosure. Based on that evaluation, our principal executive and principal financial officers have concluded that our disclosure controls and procedures are effective at the reasonable assurance level.

Changes in Internal Control

Our management, including our principal executive and principal financial officers, has evaluated any changes in our internal control over financial reporting that occurred during the quarterly period ended March 31, 2009, and has concluded that there was no change that occurred during the quarterly period ended March 31, 2009 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

Item 1A. Risk Factors

There are a number of risk factors that could cause our actual results to differ materially from those that are indicated by forward-looking statements. Those factors include, without limitation, those listed below and elsewhere herein.

If we are unable to commercialize our Phase 3 and earlier development molecules, we may not be able to recover our investment in our product development and manufacturing efforts.

We have invested significant time and resources to isolate and study genes and determine their functions. We now devote most of our resources to developing proteins, antibodies and small molecules for the treatment of human disease. We are also devoting substantial resources to the maintenance of our own manufacturing capabilities, both to support clinical testing and eventual commercialization. We have made and are continuing to make substantial expenditures. Before we can commercialize a product, we must rigorously test the product in the laboratory and complete extensive human studies. We cannot assure you that the tests and studies will yield products approved for marketing by the FDA in the United States or similar regulatory authorities in other countries, or that any such products will be profitable. We will incur substantial additional costs to continue these activities. If we are not successful in commercializing our Phase 3 and earlier development molecules, we may be unable to recover the large investment we have made in research, development and manufacturing efforts.

Because we will be disclosing data from three Phase 3 trials on our two lead products this year, 2009 will be a pivotal year for the Company.

In March 2009, we reported the results from the second of our two Phase 3 clinical trials for Albuferon. In that trial Albuferon met its primary efficacy endpoint. Even though we have determined that the results from the two Albuferon trials were positive, FDA may determine that the results are insufficient either to file a Biologics License Application (“BLA”) or to obtain marketing approval. In July and November of 2009, we expect to disclose data from the two ongoing Phase 3 clinical trials for LymphoStat-B. If the results of one or both of those trials are negative, we may not have sufficient data to file a BLA with FDA. Even if we determine that the results from those trials are positive, FDA may determine that the results are insufficient either to file a BLA or to obtain marketing approval. In addition, our partners, Novartis for Albuferon and GSK for LymphoStat-B, may determine that the results of these trials do not warrant further development or commercialization and may terminate their respective collaboration agreements. If the results of these trials are not sufficient to file a BLA and obtain marketing approval for either or both products or if either of our partners terminates its collaboration agreement, our results of operations and business will be materially adversely affected and we may not have sufficient resources to continue development of these or other products.

Because our product development efforts depend on new and rapidly-evolving technologies, we cannot be certain that our efforts will be successful.

Our work depends on new, rapidly evolving technologies and on the marketability and profitability of innovative products. Commercialization involves risks of failure inherent in the development of products based on innovative technologies and the risks associated with drug development generally. These risks include the possibility that:

	•		these technologies or any or all of the Phase 3 and earlier development molecules based on these technologies will be ineffective or toxic, or otherwise fail to receive necessary regulatory clearances;

	•		the products, even if safe and effective, will be difficult to manufacture on a large scale or uneconomical to market;

	•		proprietary rights of third parties will prevent us or our collaborators from exploiting technologies or marketing products; and

	•		third parties will market superior or equivalent products.

Because we are a late-stage development company, we cannot be certain that we can develop our business or achieve profitability.

We expect to continue to incur losses and we cannot assure you that we will ever become profitable. Although we have received U.S. Government approval for our initial order of ABthrax, we cannot assure you we will receive additional orders. A number of our products are in late-stage development, however it will be several years, if ever, before we are likely to receive continuing revenue from product sales or substantial royalty payments. We will continue to incur substantial expenses relating to research, development and manufacturing efforts and human studies. Depending on the stage of development, our products may require significant further research, development, testing and regulatory approvals. We may not be able to develop products that will be commercially successful or that will generate revenue in excess of the cost of development.

We are continually evaluating our business strategy, and may modify this strategy in light of developments in our business and other factors.

We continue to evaluate our business strategy and, as a result, may modify this strategy in the future. In this regard, we may, from time to time, focus our product development efforts on different products or may delay or halt the development of various products. In addition, as a result of changes in our strategy, we may also change or refocus our existing drug discovery, development, commercialization and manufacturing activities. This could require changes in our facilities and personnel and the restructuring of various financial arrangements. For example, in March 2009, we reduced the scope of efforts in a number of our programs. This reduction should result in cost savings of approximately $18.0 million for fiscal year 2009, a portion of which comes from a reduction in headcount. However, we cannot assure you that changes will occur or that any changes that we implement will be successful.

Several years ago, we sharpened our focus on our most promising drug candidates. We reduced the number of drugs in early development and focused our resources on the drugs that address the greatest unmet medical needs with substantial growth potential. In 2006, we spun off our CoGenesys division (“CoGenesys”) as an independent company, in a transaction that was treated as a sale for accounting purposes. In 2008, CoGenesys was acquired by Teva Pharmaceuticals Industries, Ltd. (“Teva”) and became a wholly-owned subsidiary of Teva called Teva Biopharmaceuticals USA, Inc. (“Teva Bio”).

Our ability to discover and develop new products will depend on our internal research capabilities and our ability to acquire products. Our internal research capability was reduced when we completed the spin-off of CoGenesys. Although we continue to conduct research and development activities on products, our limited resources for new products may not be sufficient to discover and develop new drug candidates.

PRODUCT DEVELOPMENT RISKS

Because we have limited experience in developing and commercializing products, we may be unsuccessful in our efforts to do so.

Although we are conducting human studies with respect to a number of products, we have limited experience with these activities and may not be successful in developing or commercializing these or other products. Our ability to develop and commercialize products based on proteins, antibodies and small molecules will depend on our ability to:

	•		successfully complete laboratory testing and human studies;

	•		obtain and maintain necessary intellectual property rights to our products;

	•		obtain and maintain necessary regulatory approvals related to the efficacy and safety of our products;

	•		maintain production facilities meeting all regulatory requirements or enter into arrangements with third parties to manufacture our products on our behalf; and

	•		deploy sales and marketing resources effectively or enter into arrangements with third parties to provide these functions.

Because clinical trials for our products are expensive and protracted and their outcome is uncertain, we must invest substantial amounts of time and money that may not yield viable products.

Conducting clinical trials is a lengthy, time-consuming and expensive process. Before obtaining regulatory approvals for the commercial sale of any product, we must demonstrate through laboratory, animal and human studies that the product is both effective and safe for use in humans. We will incur substantial additional expense for and devote a significant amount of time to these studies.

Before a drug may be marketed in the U.S., a drug must be subject to rigorous preclinical testing. The results of these studies must be submitted to the FDA as part of an investigational new drug application, which is reviewed by the FDA before clinical testing in humans can begin. The results of preclinical studies do not predict clinical success. A number of potential drugs have shown promising results in early testing but subsequently failed to obtain necessary regulatory approvals. Data obtained from tests are susceptible to varying interpretations, which may delay, limit or prevent regulatory approval. Regulatory authorities may refuse or delay approval as a result of many other factors, including changes in regulatory policy during the period of product development.

Completion of clinical trials may take many years. The time required varies substantially according to the type, complexity, novelty and intended use of the product candidate. The progress of clinical trials is monitored by both the FDA and independent data monitoring committees, which may require the modification, suspension or termination of a trial if it is determined to present excessive risks to patients. Our rate of commencement and completion of clinical trials may be delayed by many factors, including:

	•		our inability to manufacture sufficient quantities of materials for use in clinical trials;

	•		variability in the number and types of patients available for each study;

	•		difficulty in maintaining contact with patients after treatment, resulting in incomplete data;

	•		unforeseen safety issues or side effects;

	•		poor or unanticipated effectiveness of products during the clinical trials; or

	•		government or regulatory delays.

To date, data obtained from our clinical trials may not be sufficient to support an application for regulatory approval without further studies. Studies conducted by us or by third parties on our behalf may not demonstrate sufficient effectiveness and safety to obtain the requisite regulatory approvals for these or any other potential products. For example, we will be submitting a BLA to the FDA for ABthrax and expect to submit a BLA for Albuferon, but the studies we have conducted to date may not be sufficient to obtain FDA approval. In addition, based on the results of a human study for a particular product candidate, regulatory authorities may not permit us to undertake any additional clinical trials for that product candidate. The clinical trial process may also be accompanied by substantial delay and expense and there can be no assurance that the data generated in these studies will ultimately be sufficient for marketing approval by the FDA. For example, in 2005, we discontinued our clinical development of LymphoRad131, a product candidate to treat cancer. We also discontinued development of HGS-TR2J and returned all rights to Kirin Brewery Company, Ltd.

The development programs for Albuferon and LymphoStat-B have each involved two large-scale, multi-center Phase 3 clinical trials and have been more expensive than our Phase 1 and Phase 2 clinical trials. In December 2008 and March 2009, we announced that we had completed the Phase 3 studies for Albuferon; in both studies, Albuferon met its primary efficacy endpoint of non-inferiority to peginterferon alfa-2a. We are conducting an ongoing Phase 3 clinical development program for LymphoStat-B and expect to disclose data in July and November of 2009. We cannot assure you that we will be able to complete our LymphoStat-B Phase 3 clinical trials successfully or obtain FDA approval of Albuferon or LymphoStat-B, or that FDA approval, if obtained, will not include limitations on the indicated uses for which Albuferon and/or LymphoStat-B may be marketed.

We face risks in connection with our ABthrax product in addition to risks generally associated with drug development.

The development of ABthrax presents risks beyond those associated with the development of our other products. Numerous other companies and governmental agencies are known to be developing biodefense pharmaceuticals and related products to combat anthrax. These competitors may have financial or other resources greater than ours, and may have easier or preferred access to the likely distribution channels for biodefense products. In addition, since the primary purchaser of biodefense products is the U.S. Government and its agencies, the success of ABthrax will depend on government spending policies and pricing restrictions. The funding of government biodefense programs is dependent, in part, on budgetary constraints, political considerations and military developments. In the case of the U.S. Government, executive or legislative action could attempt to impose production and pricing requirements on us. We have entered into a two-phase contract to supply ABthrax, a human monoclonal antibody developed for use in the treatment of anthrax disease, to the U.S. Government. Under the first phase of the contract, we supplied ten grams of ABthrax to the U.S. Department of Health and Human Services (“HHS”) for comparative in vitro and in vivo testing. Under the second phase of the contract, the U.S. Government ordered 20,001 doses of ABthrax for the Strategic National Stockpile for use in the treatment of anthrax disease. We have begun delivery of these doses and the U.S. Government has accepted our initial deliveries. We have future deliveries to make and have ongoing obligations under the contract, including the obligation to file a BLA and to obtain FDA approval. We will continue to face risks related to these future deliveries and the requirements of the contract. If we are unable to complete these deliveries or to meet our obligations associated with this contract, the U.S. Government will not be required to make future payments related to that order. In addition, we are in discussions with the U.S. Government concerning the possibility of future orders of ABthrax. We cannot assure you that we will be successful in obtaining an order for additional doses of ABthrax or, if we are successful in obtaining an order, that we will be successful in fulfilling that order.

Because neither we nor any of our collaboration partners have received marketing approval for any product candidate resulting from our research and development efforts, and because we may never be able to obtain any such approval, it is possible that we may not be able to generate any product revenue other than with respect to ABthrax.

Although two of our potential products have entered and completed clinical trials, we cannot assure you that any of these products will receive marketing approval. It is possible that we will not receive FDA marketing approval for any of our product candidates even if the results of the clinical trials are positive. All products being developed by our collaboration partners will also require additional research and development, extensive preclinical studies and clinical trials and regulatory approval prior to any commercial sales. In some cases, the length of time that it takes for our collaboration partners to achieve various regulatory approval milestones may affect the payments that we are eligible to receive under our collaboration agreements. We and our collaboration partners may need to successfully address a number of technical challenges in order to complete development of our products. Moreover, these products may not be effective in treating any disease or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining regulatory approval or prevent or limit commercial use.

RISK FROM COLLABORATION RELATIONSHIPS AND STRATEGIC ACQUISITIONS

Our plan to use collaborations to leverage our capabilities and to grow in part through the strategic acquisition of other companies and technologies may not be successful if we are unable to integrate our partners’ capabilities or the acquired companies with our operations or if our partners’ capabilities do not meet our expectations.

As part of our strategy, we intend to continue to evaluate strategic partnership opportunities and consider acquiring complementary technologies and businesses. In order for our future collaboration efforts to be successful, we must first identify partners whose capabilities complement and integrate well with ours. Technologies to which we gain access may prove ineffective or unsafe. Our current agreements that grant us access to such technology may expire and may not be renewable or could be terminated if we or our partners do not meet our obligations. These agreements are subject to differing interpretations and we and our partners may not agree on the appropriate interpretation of specific requirements. Our partners may prove difficult to work with or less skilled than we originally expected. In addition, any past collaborative successes are no indication of potential future success.

In order to achieve the anticipated benefits of an acquisition, we must integrate the acquired company’s business, technology and employees in an efficient and effective manner. The successful combination of companies in a rapidly changing biotechnology industry may be more difficult to accomplish than in other industries. The combination of two companies requires, among other things, integration of the companies’ respective technologies and research and development efforts. We cannot assure you that this integration will be accomplished smoothly or successfully. The difficulties of integration may be increased by any need to coordinate geographically separated organizations and address possible differences in corporate cultures and management philosophies. The integration of certain operations will require the dedication of management resources which may temporarily distract attention from the day-to-day operations of the combined companies. The business of the combined companies may also be disrupted by employee retention uncertainty and lack of focus during integration. The inability of management to integrate successfully the operations of the two companies, in particular, the integration and retention of key personnel, or the inability to integrate successfully two technology platforms, could have a material adverse effect on our business, results of operations and financial condition.

We reacquired rights to HGS-ETR1 from GSK, as well as all rights to other TRAIL Receptor 1 and 2 antibodies. We may be unsuccessful in developing and commercializing products from these antibodies without a collaborative partner.

As part of our September 1996 agreement with GSK, we granted a 50/50 co-development and commercialization option to GSK for certain human therapeutic products that successfully complete Phase 2a clinical trials. In August 2005, we announced that GSK had exercised its option to develop and commercialize HGS-ETR1 (mapatumumab) jointly with us. In April 2008, we announced that we had reacquired all rights to our TRAIL receptor antibodies (including rights to HGS-ETR1 and HGS-ETR2) from GSK, in return for a reduction in royalties due to us if Syncria^®, a GSK product for which we would be owed royalties, is commercialized. We also announced that our agreement with the pharmaceutical division of Kirin Brewery Company, Ltd. for joint development of antibodies to TRAIL receptor 2 had been terminated. Takeda Pharmaceutical Company, Ltd. has the right to develop HGS-ETR1 in Japan. As a result of these actions, we have assumed full responsibility for the development and commercialization of products based on these antibodies, except for HGS-ETR1 in Japan.

Our ability to receive revenues from the assets licensed in connection with our CoGenesys transaction will now depend on Teva Bio’s ability to develop and commercialize those assets.

We will depend on Teva Bio to develop and commercialize the assets licensed as part of the spin-off of CoGenesys. If Teva Bio is not successful in its efforts, we will not receive any revenue from the development of these assets. In addition, our relationship with Teva Bio will be subject to the risks and uncertainties inherent in our other collaborations.

Because we currently depend on our collaboration partners for substantial revenue, we may not become profitable if we cannot increase the revenue from our collaboration partners or other sources.

We have received substantial revenue from payments made under collaboration agreements with GSK and Novartis, and to a lesser extent, other agreements. The research term of our initial GSK collaboration agreement and many of our other collaboration agreements expired in 2001. None of these collaboration agreements was renewed and we may not be able to enter into additional collaboration agreements. While our partners under our initial GSK collaboration agreement have informed us that they have been pursuing research programs involving different genes for the creation of small molecule, protein and antibody drugs, we cannot assure you that any of these programs will be continued or will result in any approved drugs.

Under the Novartis and GSK collaboration agreements, we are entitled to certain development and commercialization payments based on our development of the applicable product. Under our other collaboration agreements, we are entitled to certain milestone and royalty payments based on our partners’ development of the applicable product.

We may not receive payments under these agreements if we or our collaborators fail to:

	•		develop marketable products;

	•		obtain regulatory approvals for products; or

	•		successfully market products.

Further, circumstances could arise under which one or more of our collaboration partners may allege that we breached our agreement with them and, accordingly, seek to terminate our relationship with them. Our collaboration partners may also terminate these agreements without cause. If any one of these agreements terminates, this could adversely affect our ability to commercialize our products and harm our business.

If one of our collaborators pursues a product that competes with our products, there could be a conflict of interest and we may not receive milestone or royalty payments.

Each of our collaborators is developing a variety of products, some with other partners. Our collaborators may pursue existing or alternative technologies to develop drugs targeted at the same diseases instead of using our licensed technology to develop products in collaboration with us. Our collaborators may also develop products that are similar to or compete with products they are developing in collaboration with us. If our collaborators pursue these other products instead of our products, we may not receive milestone or royalty payments. For example, GSK has been developing for the treatment of insomnia an orexin inhibitor based on our technology and to which we are entitled to milestones, royalties and co-promotion rights. In July 2008, GSK announced a collaboration with Actelion Ltd. to co-develop and co-commercialize a different orexin inhibitor. While GSK has stated publicly that it intends to continue work on the inhibitor derived from our technology, there can be no assurance that it will continue to do so or that such work will lead to a commercial product.

Many of our competitors have substantially greater capabilities and resources and may be able to develop and commercialize products before we do.

We face intense competition from a wide range of pharmaceutical and biotechnology companies, as well as academic and research institutions and government agencies.

Principal competitive factors in our industry include:

	•		the quality and breadth of an organization’s technology;

	•		the skill of an organization’s employees and ability to recruit and retain skilled employees;

	•		an organization’s intellectual property portfolio;

	•		the range of capabilities, from target identification and validation to drug discovery and development to manufacturing and marketing; and

	•		the availability of substantial capital resources to fund discovery, development and commercialization activities.

Many large pharmaceutical and biotechnology companies have significantly larger intellectual property estates than we do, more substantial capital resources than we have, and greater capabilities and experience than we do in preclinical and clinical development, sales, marketing, manufacturing and regulatory affairs.

We are aware of existing products and products in research or development by our competitors that address the diseases we are targeting. Any of these products may compete with our product candidates. Our competitors may succeed in developing their products before we do, obtaining approvals from the FDA or other regulatory agencies for their products more rapidly than we do, or developing products that are more effective than our products. These products or technologies might render our technology or drugs under development obsolete or noncompetitive. In addition, our albumin fusion protein product is designed to be longer-acting versions of existing products. The existing product in many cases has an established market that may make the introduction of our product more difficult.

If our products are approved and marketed, we may also face risks from generic drug manufacturers. Legislation currently pending in Congress and regulatory and legislative activity in other countries may make it easier for generic drug manufacturers to manufacture and sell in the United States biological drugs similar or identical to Albuferon and LymphoStat-B, which might affect the profitability or commercial viability of our products.

Since reimbursement payments from our collaborators will pay for approximately half of our late-phase clinical trial expenses, our ability to develop and commercialize products may be impaired if payments from our collaborators are delayed.

We are conducting Phase 3 clinical development programs for both Albuferon and LymphoStat-B. These development programs include four Phase 3 large-scale, multi-center clinical trials, only two of which have been completed. We rely on our collaborators to reimburse us for approximately half of the expenditures related to these programs. To execute our Phase 3 clinical trial programs, including the filings of BLAs, we strengthened our development organization and increased our dependence on third-party contract clinical trial providers. The collaboration agreements with our partners in the development of these two products provide for the reimbursement of approximately half of these increased expenditures. However, our collaborators may not agree with our expenses or may not perform their obligations under our agreements with them. Further, it is difficult to accurately predict or control the amount or timing of these expenditures, and uneven and unexpected spending on these programs may cause our operating results to fluctuate from quarter to quarter. As a result, if we are unable to obtain funding under these agreements on a timely basis, we may be forced to delay, curtail or terminate these Phase 3 trials or the filings of the BLAs, which could adversely affect our ability to commercialize our products and harm our business.

FINANCIAL AND MARKET RISKS

Because of our substantial indebtedness, we may be unable to adjust our strategy to meet changing conditions in the future.

As of March 31, 2009, we had long-term obligations of approximately $581.3 million of which $334.3 million ($403.9 million on a face value basis) represents convertible debt. During the year ended December 31, 2008, we made interest and principal payments of $35.0 million on our indebtedness and during the three months ended March 31, 2009, we made interest and principal payments of $9.1 million on our indebtedness. In February 2009, we repurchased approximately $82.9 million of the 2011 debt and $23.3 million of the 2012 debt at a cost of approximately $50.0 million plus accrued interest. Our substantial debt will have several important consequences for our future operations. For instance:

	•		payments of interest on, and principal of, our indebtedness will be substantial and may exceed then current income and available cash;

	•		we may be unable to obtain additional future financing for continued clinical trials, capital expenditures, acquisitions or general corporate purposes;

	•		we may be unable to withstand changing competitive pressures, economic conditions and governmental regulations; and

	•		we may be unable to make acquisitions or otherwise take advantage of significant business opportunities that may arise.

We may not have adequate resources available to repay our convertible subordinated debt when it becomes due.

As of March 31, 2009, we had $403.9 million in face value convertible subordinated debt outstanding, with $197.1 million and $206.8 million due in 2011 and 2012, respectively. This debt is convertible into our common stock at a conversion price of approximately $15.55 and $17.78 per share, respectively. If our stock price does not exceed the applicable conversion price when the remaining debt matures, we may need to pay the note holders in cash or restructure some or all of the debt. Since it may be several years, if ever, before we are likely to receive continuing revenue from product sales or substantial royalty payments, we may not have enough cash, cash equivalents, short- term investments and marketable securities available to repay the remaining debt in 2011 and 2012.

To become a successful biopharmaceutical company, we are likely to need additional funding in the future. If we do not obtain this funding on acceptable terms, we may not be able to generate sufficient revenue to repay our convertible debt, to launch and market successfully our products and to continue our biopharmaceutical discovery and development efforts.

We continue to expend substantial funds on our research and development programs and human studies on current and future drug candidates. If our Phase 3 programs are successful, we will begin to expend significant funds to support pre-launch and commercial marketing activities. We may need additional financing to fund our operating expenses, including pre-commercial launch activities, marketing activities, research and development and capital requirements. In addition, even if our products are successful, if our stock price does not exceed the applicable conversion price when our remaining convertible debt matures, we may need to pay the note holders in cash or restructure some or all of the debt. If we are unable to restructure the debt, we may not have enough cash, cash equivalents, short-term investments and marketable securities available to repay the remaining debt. We may not be able to obtain additional financing on acceptable terms either to fund operating expenses or to repay the convertible debt. If we raise additional funds by issuing equity securities, equity-linked securities or debt securities, the new equity securities may dilute the interests of our existing stockholders and the new debt securities may contain restrictive financial covenants.

Our need for additional funding will depend on many factors, including, without limitation:

	•		the amount of revenue or cost sharing, if any, that we are able to obtain from our collaborations, any approved products, and the time and costs required to achieve those revenues;

	•		the timing, scope and results of preclinical studies and clinical trials;

	•		the size and complexity of our development programs;

	•		the time and costs involved in obtaining regulatory approvals;

	•		the costs of launching our products;

	•		the costs of commercializing our products, including marketing, promotional and sales costs;

	•		the commercial success of our products;

	•		our stock price;

	•		our ability to establish and maintain collaboration partnerships;

	•		competing technological and market developments;

	•		the costs involved in filing, prosecuting and enforcing patent claims; and

	•		scientific progress in our research and development programs.

If we are unable to raise additional funds, we may, among other things:

	•		delay, scale back or eliminate some or all of our research and development programs;

	•		delay, scale back or eliminate some or all of our commercialization activities;

	•		lose rights under existing licenses;

	•		relinquish more of, or all of, our rights to product candidates on less favorable terms than we would otherwise seek; and

	•		be unable to operate as a going concern.

Our short-term investments, marketable securities and restricted investments are subject to certain risks which could materially adversely affect our overall financial position.

We invest our cash in accordance with an established internal policy and customarily in instruments which historically have been highly liquid and carried relatively low risk. However, the capital and credit markets have been experiencing extreme volatility and disruption. In recent months, the volatility and disruption have reached unprecedented levels. We maintain a significant portfolio of investments in short-term investments, marketable debt securities and restricted investments, which are recorded at fair value. Certain of these transactions expose us to credit risk in the event of default of the issuer. To minimize our exposure to credit risk, we invest in securities with strong credit ratings and have established guidelines relative to diversification and maturity with the objective of maintaining safety of principal and liquidity. We do not invest in derivative financial instruments or auction rate securities, and we generally hold our investments in debt securities until maturity. In September 2008, Lehman Brothers Holdings, Inc. (“LBHI”) filed for bankruptcy and the debt securities issued by LBHI experienced a significant decline in market value, which caused an other-than-temporary impairment of our investment in LBHI. As a result, we recorded an impairment charge of $6.3 million during 2008. In recent months, certain financial instruments, including some of the securities in which we invest, have sustained downgrades in credit ratings and some high quality short term investment securities have suffered illiquidity or events of default. Further deterioration in the credit market may have a further adverse effect on the fair value of our investment portfolio. Should any of our short-term investments, marketable securities or restricted investments lose additional value or have their liquidity impaired, it could materially and adversely affect our overall financial position by imperiling our ability to fund our operations and forcing us to seek additional financing sooner than we would otherwise. Such financing may not be available on commercially attractive terms or at all.

Some of our operating leases contain financial covenants, which may require us to accelerate payment under those agreements or increase the amount of our security deposits.

Under the leases for some of our equipment and our process development and small-scale manufacturing facility, we must maintain minimum levels of unrestricted cash, cash equivalents, marketable securities and net worth. During 2007, we amended certain of these leases to eliminate the minimum net worth covenant and adjust the minimum levels of unrestricted cash, cash equivalents and marketable securities required under the leases. We also pledged additional collateral to another lessor to satisfy the minimum net worth covenant associated with certain other leases. With respect to the small-scale manufacturing facility lease, we increased the amount of our security deposits in 2007 by approximately $1.0 million, raising the level in 2007 to $15.0 million. Under certain circumstances pertaining to this facility lease, if we do not elect to purchase the facility, we could lose either a portion or all of our restricted investments and record a charge to earnings for such a loss.

Our insurance policies are expensive and protect us only from some business risks, which could leave us exposed to significant, uninsured liabilities.

We do not carry insurance for all categories of risk that our business may encounter. We currently maintain general liability, property, auto, workers’ compensation, products liability, fiduciary and directors’ and officers’ insurance policies. We do not know, however, if we will be able to maintain existing insurance with adequate levels of coverage. For example, the premiums for our directors’ and officers’ insurance policy have increased in the past and may increase in the future, and this type of insurance may not be available on acceptable terms or at all in the future. Any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our cash position and results of operations.

INTELLECTUAL PROPERTY RISKS

If our patent applications do not result in issued patents or if patent laws or the interpretation of patent laws change, our competitors may be able to obtain rights to and commercialize our discoveries.

Our pending patent applications, including those covering full-length genes and their corresponding proteins, may not result in the issuance of any patents. Our applications may not be sufficient to meet the statutory requirements for patentability in all cases or may be subject to challenge, if they do issue. Important legal issues remain to be resolved as to the extent and scope of available patent protection for biotechnology products and processes in the U.S. and other important markets outside the U.S., such as Europe and Japan. In the U.S., Congress is considering significant changes to U.S. intellectual property laws which could affect the extent and scope of existing protections for biotechnology products and processes. Foreign markets may not provide the same level of patent protection as provided under the U.S. patent system. We expect that litigation or administrative proceedings will likely be necessary to determine the validity and scope of certain of our and others’ proprietary rights. We are currently involved in a number of litigation and administrative proceedings relating to the scope of protection of our patents and those of others in both the United States and in the rest of the world.

We are involved in a number of interference proceedings brought by the United States Patent and Trademark Office and may be involved in other interference proceedings in the future. These proceedings determine the priority of inventions and, thus, the right to a patent for technology in the U.S. For example, we are involved in interferences in the United States with both Genentech, Inc. and Immunex Corporation, a wholly-owned subsidiary of Amgen, Inc., related to products based on TRAIL Receptor 2 (such as HGS-ETR2). In three of these interferences, we have initiated district court litigation to review adverse decisions by the United States Patent and Trademark Office. In two of these cases, we are also seeking appellate review of a jurisdictional issue decided by the district court. Additional litigation related to these TRAIL Receptor 2 interferences is likely.

We are also involved in proceedings in connection with foreign patent filings, including opposition and revocation proceedings and may be involved in other opposition proceedings in the future. For example, we are involved in European opposition proceedings against an issued patent of Biogen Idec. In this opposition, the European Patent Office (“EPO”) found the claims of Biogen Idec’s patent to be valid. The claims relate to a method of treating autoimmune diseases using an antibody to BLyS (such as LymphoStat-B). We and GSK have entered into a definitive license agreement with Biogen Idec that provides for an exclusive license to this European patent. This patent is still under appeal in Europe. We also are involved in an opposition proceeding brought by Eli Lilly and Company with respect to our European patent related to BLyS compositions, including antibodies. In 2008, the Opposition Division of the EPO held our patent invalid. We have appealed this decision. In addition, Eli Lilly and Company instituted a revocation proceeding against our United Kingdom patent that corresponds to our BLyS European patent; in this proceeding the UK trial court found the patent invalid. We have appealed this decision.

We have also opposed European patents issued to Genentech, Inc. and Immunex Corporation related to products based on TRAIL Receptor 2, and Genentech, Inc. and Immunex Corporation have opposed our European patents related to products based on TRAIL Receptor 2. Genentech, Inc. also has opposed our Australian patent related to products based on TRAIL Receptor 2. In addition, Genentech, Inc. has opposed our European patent related to products based on TRAIL Receptor 1 (such as HGS-ETR1).

We cannot assure you that we will be successful in any of these proceedings. Moreover, any such litigation or proceeding may result in a significant commitment of resources in the future and could force us to do one or more of the following: cease selling or using any of our products that incorporate the challenged intellectual property, which would adversely affect our revenue; obtain a license from the holder of the intellectual property right alleged to have been infringed, which license may not be available on reasonable terms, if at all; and redesign our products to avoid infringing the intellectual property rights of third parties, which may be time-consuming or impossible to do. In addition, such litigation or proceeding may allow others to use our discoveries or develop or commercialize our products. Changes in, or different interpretations of, patent laws in the U.S. and other countries may result in patent laws that allow others to use our discoveries or develop and commercialize our products or prevent us from using or commercializing our discoveries and products. We cannot assure you that the patents we obtain or the unpatented technology we hold will afford us significant commercial protection.

If others file patent applications or obtain patents similar to ours, then the United States Patent and Trademark Office may deny our patent applications, or others may restrict the use of our discoveries.

We are aware that others, including universities and companies working in the biotechnology and pharmaceutical fields, have filed patent applications and have been granted patents in the U.S. and in other countries that cover subject matter potentially useful or necessary to our business. Some of these patents and patent applications claim only specific products or methods of making products, while others claim more general processes or techniques useful in the discovery and manufacture of a variety of products. The risk of third parties obtaining additional patents and filing patent applications will continue to increase as the biotechnology industry expands. We cannot predict the ultimate scope and validity of existing patents and patents that may be granted to third parties, nor can we predict the extent to which we may wish or be required to obtain licenses to such patents, or the availability and cost of acquiring such licenses. To the extent that licenses are required, the owners of the patents could bring legal actions against us to claim damages or to stop our manufacturing and marketing of the affected products. We believe that there will continue to be significant litigation in our industry regarding patent and other intellectual property rights. If we become involved in litigation, it could consume a substantial portion of our resources.

Because issued patents may not fully protect our discoveries, our competitors may be able to commercialize products similar to those covered by our issued patents.

Issued patents may not provide commercially meaningful protection against competitors and may not provide us with competitive advantages. Other parties may challenge our patents or design around our issued patents or develop products providing effects similar to our products. In addition, others may discover uses for genes, proteins or antibodies other than those uses covered in our patents, and these other uses may be separately patentable. The holder of a patent covering the use of a gene, protein or antibody for which we have a patent claim could exclude us from selling a product for a use covered by its patent.

We rely on our collaboration partners to seek patent protection for the products they develop based on our research.

A significant portion of our future revenue may be derived from royalty payments from our collaboration partners. These partners face the same patent protection issues that we and other biotechnology or pharmaceutical firms face. As a result, we cannot assure you that any product developed by our collaboration partners will be patentable, and therefore, revenue from any such product may be limited, which would reduce the amount of any royalty payments. We also rely on our collaboration partners to effectively prosecute their patent applications. Their failure to obtain or protect necessary patents could also result in a loss of royalty revenue to us.

If we are unable to protect our trade secrets, others may be able to use our secrets to compete more effectively.

We may not be able to meaningfully protect our trade secrets. We rely on trade secret protection to protect our confidential and proprietary information. We believe we have acquired or developed proprietary procedures and materials for the production of proteins and antibodies. We have not sought patent protection for these procedures. While we have entered into confidentiality agreements with employees and collaborators, we may not be able to prevent their disclosure of these data or materials. Others may independently develop substantially equivalent information and processes.

REGULATORY RISKS

Because we are subject to extensive changing government regulatory requirements, we may be unable to obtain government approval of our products in a timely manner.

Regulations in the U.S. and other countries have a significant impact on our research, product development and manufacturing activities and will be a significant factor in the marketing of our products. All of our products require regulatory approval prior to commercialization. In particular, our products are subject to rigorous preclinical and clinical testing and other premarket approval requirements by the FDA and similar regulatory authorities in other countries, such as Europe and Japan. Various statutes and regulations also govern or influence the manufacturing, safety, labeling, storage, record keeping and marketing of our products. The lengthy process of seeking these approvals, and the subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources. Any failure by us to obtain, or any delay in obtaining, regulatory approvals could materially adversely affect our ability to commercialize our products in a timely manner, or at all.

Marketing Approvals. Before a product can be marketed and sold in the U.S., the results of the preclinical and clinical testing must be submitted to the FDA for approval. This submission will be either a new drug application or a biologics license application, depending on the type of drug. In responding to a new drug application or a biologics license application, the FDA may grant marketing approval, request additional information or deny the application if it determines that the application does not provide an adequate basis for approval. We cannot assure you that any approval required by the FDA will be obtained on a timely basis, or at all.

In addition, the FDA may condition marketing approval on the conduct of specific post-marketing studies to further evaluate safety and efficacy. Rigorous and extensive FDA regulation of pharmaceutical products continues after approval, particularly with respect to compliance with current good manufacturing practices, or cGMPs, reporting of adverse effects, advertising, promotion and marketing. Discovery of previously unknown problems or failure to comply with the applicable regulatory requirements may result in restrictions on the marketing of a product or withdrawal of the product from the market as well as possible civil or criminal sanctions, any of which could materially adversely affect our business.

Foreign Regulation. We must obtain regulatory approval by governmental agencies in other countries prior to commercialization of our products in those countries. Foreign regulatory systems may be just as rigorous, costly and uncertain as in the U.S.

Because we are subject to environmental, health and safety laws, we may be unable to conduct our business in the most advantageous manner.

We are subject to various laws and regulations relating to safe working conditions, laboratory and manufacturing practices, the experimental use of animals, emissions and wastewater discharges, and the use and disposal of hazardous or potentially hazardous substances used in connection with our research, including radioactive compounds and infectious disease agents. We also cannot accurately predict the extent of regulations that might result from any future legislative or administrative action. Any of these laws or regulations could cause us to incur additional expense or restrict our operations.

OTHER RISKS RELATED TO OUR BUSINESS

If our proposed amended and restated stock incentive plan is not approved by our stockholders, we may not be able to attract, retain and motivate our current and new employees and our operations may be adversely affected.

Our current stock incentive plan is scheduled to terminate on February 15, 2010 or at an earlier date if the shares available for issuance are exhausted. Our Board of Directors has recommended that our stockholders approve an amended and restated stock incentive plan at our 2009 Annual Meeting. The proposed plan would extend the stock incentive plan until February 15, 2015 and increase the number of shares available for issuance by 1,500,000. If our stockholders do not approve the amended and restated stock incentive plan, we may not have sufficient shares to continue to award stock options or restricted stock at competitive levels to current and new employees, and we will be unable to issue any stock options or restricted stock after February 2010. Our inability to make these awards may adversely affect our ability to attract, retain and motivate our current and new employees. If we are unable to attract, retain and motivate our employees, development and commercialization of our products may be adversely affected.

If we lose or are unable to attract key management or other personnel, we may experience delays in product development.

We depend on our senior executive officers as well as other key personnel. If any key employee decides to terminate his or her employment with us, this termination could delay the commercialization of our products or prevent us from becoming profitable. Competition for qualified employees is intense among pharmaceutical and biotechnology companies, and the loss of qualified employees, or an inability to attract, retain and motivate additional highly skilled employees required for the expansion of our activities, could hinder our ability to complete human studies successfully and develop marketable products. The reduction in scope of some programs in March 2009 included decreasing headcount. This reduction in headcount may adversely affect our ability to attract, retain and motivate current and new employees.

If the health care system or reimbursement policies change, the prices of our potential products may be lower than expected and our potential sales may decline.

The levels of revenues and profitability of biopharmaceutical companies like ours may be affected by the continuing efforts of government and third party payers to contain or reduce the costs of health care through various means. For example, in certain foreign markets, pricing or profitability of therapeutic and other pharmaceutical products is subject to governmental control. In the U.S., there have been, and we expect that there will continue to be, a number of federal and state proposals to implement similar governmental control. In addition, in the U.S., a number of proposals have been made to reduce the regulatory burden of follow-on biologics, which could affect the prices and sales of our products in the future. Additional proposals may occur as a result of a change in the presidential administration in January 2009. While we cannot predict whether any legislative or regulatory proposals will be adopted, the adoption of such proposals could have a material adverse effect on our business, financial condition and profitability. In addition, in the U.S. and elsewhere, sales of therapeutic and other pharmaceutical products depend in part on the availability of reimbursement to the consumer from third party payers, such as government and private insurance plans. Third party payers are increasingly challenging the prices charged for medical products and services. We cannot assure you that any of our products will be considered cost effective or that reimbursement to the consumer will be available or will be sufficient to allow us to sell our products on a competitive and profitable basis.

We may be unable to successfully establish a manufacturing capability and may be unable to obtain required quantities of our Phase 3 and earlier development molecules economically.

We have not yet manufactured any products approved for commercial use and, except for ABthrax, have limited experience in manufacturing materials suitable for commercial use. We have only limited experience manufacturing in a large-scale manufacturing facility built to increase our capacity for protein and antibody drug production. The FDA must inspect and license our facilities to determine compliance with cGMP requirements for commercial production. We may not be able to successfully establish sufficient manufacturing capabilities or manufacture our products economically or in compliance with cGMPs and other regulatory requirements.

While we have expanded our manufacturing capabilities, we have previously contracted and may in the future contract with third party manufacturers or develop products with collaboration partners and use the collaboration partners’ manufacturing capabilities. If we use others to manufacture our products, we will depend on those parties to comply with cGMPs, and other regulatory requirements and to deliver materials on a timely basis. These parties may not perform adequately. Any failures by these third parties may delay our development of products or the submission of these products for regulatory approval.

We may be unable to fulfill the terms of our agreement with Hospira, Inc. and other agreements, if any, with potential customers for manufacturing process development and supply of selected biopharmaceutical products.

We have entered into agreements for manufacturing process development, clinical and commercial supply of certain biopharmaceutical products, including an agreement with Hospira, Inc., and may enter into similar agreements with other potential customers. We may not be able to successfully manufacture products under the agreement with Hospira or under other agreements, if any. We have not yet manufactured any products approved for commercial use and, except for ABthrax, have limited experience in manufacturing materials suitable for commercial use. We have limited experience manufacturing in a large-scale manufacturing facility built to increase our capacity for protein and antibody drug production. The FDA must inspect and license our facilities to determine compliance with cGMP requirements for commercial production. We may not be able to enter into additional agreements with other customers. Hospira or any future customer may decide to discontinue the products contemplated under the agreements, and therefore we may not receive revenue from these agreements.

Because we currently have only a limited marketing capability, we may be unable to sell any of our products effectively.

We do not have any marketed products, although we have sold ABthrax to the U.S. Government. If we develop products that can be marketed, we intend to market the products either independently or together with collaborators or strategic partners. GSK, Novartis and others have co-marketing rights with respect to certain of our products. If we decide to market any products, either independently or together with partners, we will incur significant additional expenditures and commit significant additional management resources to establish a sales force. For any products that we market together with partners, we will rely, in whole or in part, on the marketing capabilities of those parties. We may also contract with third parties to market certain of our products. Ultimately, we and our partners may not be successful in marketing our products.

Because we depend on third parties to conduct many of our human studies, we may encounter delays in or lose some control over our efforts to develop products.

We are dependent on third-party research organizations to conduct most of our human studies. We have engaged contract research organizations to manage our global Phase 3 studies. If we are unable to obtain any necessary services on acceptable terms, we may not complete our product development efforts in a timely manner. If we rely on third parties for the management of these human studies, we may lose some control over these activities and become too dependent upon these parties. These third parties may not complete the activities on schedule.

Our certificate of incorporation and bylaws could discourage acquisition proposals, delay a change in control or prevent transactions that are in your best interests.

Provisions of our certificate of incorporation and bylaws, as well as Section 203 of the Delaware General Corporation Law, may discourage, delay or prevent a change in control of our company that you as a stockholder may consider favorable and may be in your best interest. Our certificate of incorporation and bylaws contain provisions that:

	•		authorize the issuance of up to 20,000,000 shares of “blank check” preferred stock that could be issued by our board of directors to increase the number of outstanding shares and discourage a takeover attempt;

	•		limit who may call special meetings of stockholders; and

	•		establish advance notice requirements for nomination of candidates for election to the board of directors or for proposing matters that can be acted upon by stockholders at stockholder meetings.

Because our stock price has been and will likely continue to be volatile, the market price of our common stock may be lower or more volatile than you expected.

Our stock price, like the stock prices of many other biotechnology companies, has been highly volatile. For the twelve months ended March 31, 2009, the closing price of our common stock has been as low as $0.48 per share and as high as $7.94 per share. The market price of our common stock could fluctuate widely because of:

	•		future announcements about our company or our competitors, including the results of testing, technological innovations or new commercial products;

	•		negative regulatory actions with respect to our potential products or regulatory approvals with respect to our competitors’ products;


	Page
	Number
PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

Consolidated Statements of Operations for the three months ended March 31, 2009 and 2008		3
Consolidated Balance Sheets at March 31, 2009 and December 31, 2008		4
Consolidated Statements of Cash Flows for the three months ended March 31, 2009 and 2008		5
Notes to Consolidated Financial Statements		7

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations		18

Item 3. Quantitative and Qualitative Disclosures about Market Risk		25

Item 4. Controls and Procedures		26

PART II. OTHER INFORMATION

Item 1A. Risk Factors		27

Item 6. Exhibits		42

Signatures		43

Exhibit Index	Exhibit Volume
EX-12.1
EX-31.I.1
EX-31.I.2
EX-32.1
EX-32.2


12.1		Ratio of Earnings to Fixed Charges.

31i.1		Rule 13a-14(a) Certification of Principal Executive Officer.

31i.2		Rule 13a-14(a) Certification of Principal Financial Officer.

32.1		Section 1350 Certification of Principal Executive Officer.

32.2		Section 1350 Certification of Principal Financial Officer.



		HUMAN GENOME SCIENCES, INC.

		BY:		/s/ H. Thomas Watkins

				H. Thomas Watkins
				President and Chief Executive Officer
				(Principal Executive Officer)

		BY:		/s/ Timothy C. Barabe

				Timothy C. Barabe
				Chief Financial Officer and Senior Vice President
				(Principal Financial Officer and Principal Accounting Officer)


12.1		Ratio of Earnings to Fixed Charges.

31i.1		Rule 13a-14(a) Certification of Principal Executive Officer.

31i.2		Rule 13a-14(a) Certification of Principal Financial Officer.

32.1		Section 1350 Certification of Principal Executive Officer.

32.2		Section 1350 Certification of Principal Financial Officer.


	Ratio of Earnings to Fixed Charges
	(dollars in thousands, except ratio data)
	Three
	months
	ended		Year ended December 31,
	March 31,
	2009		2008			2007			2006⁽¹⁾			2005⁽¹⁾			2004⁽¹⁾
			Restated			Restated
Earnings (Loss):
Earnings (loss) before provision for income taxes	$	129,813	$	(268,891	)	$	(284,370	)	$	(251,173	)	$	(239,439	)	$	(242,898	)
Fixed Charges		20,566		82,930			80,927			49,391			32,463			31,957


Total Earnings (Loss)	$	150,379	$	(185,961	)	$	(203,443	)	$	(201,782	)	$	(206,976	)	$	(210,941	)


Fixed Charges:
Interest expense on indebtedness (including amortization of debt expense and discount)	$	15,730	$	62,912		$	60,716		$	29,492		$	17,849		$	22,868
Interest expense on portion of rent expense representative of interest		4,836		20,018			20,211			19,899			14,614			9,089


Total Fixed Charges	$	20,566	$	82,930		$	80,927		$	49,391		$	32,463		$	31,957


Ratio of Earnings to Fixed Charges ⁽²⁾		7.31		—			—			—			—			—

Coverage deficiency ^(3)(4)(5)		—	$	(268,891	)	$	(284,370	)	$	(251,173	)	$	(239,439	)	$	(242,898	)

	•		changes in government regulations;

	•		developments in our relationships with our collaboration partners;

	•		developments affecting our collaboration partners;

	•		announcements relating to health care reform and reimbursement levels for new drugs;

	•		our failure to acquire or maintain proprietary rights to the gene sequences we discover or the products we develop;

	•		litigation; and

	•		public concern as to the safety of our products.


(1)		The Company adopted FSP APB 14-1 effective January 1, 2009 using the financial statement approach, which resulted in the cumulative effect of a change in accounting principle being recorded as of January 1, 2007, and has restated its 2007 and 2008 financial information, but not 2006, 2005, or 2004.

(2)		The Company’s Ratio of Earnings to Fixed Charges for the three months ended March 31, 2009 includes a gain on extinguishment of debt of $38,873 and gain on the sale of an equity investment of $5,259.

(3)		The Company’s Coverage deficiency for 2008 includes a gain on the sale of an equity investment of $32,518.

(4)		The Company’s Coverage deficiency for 2006 includes charges for lease termination and restructuring costs of $29,510 partially offset by a gain on the sale of an equity investment of $14,759.

(5)		The Company’s Coverage deficiency for 2004 includes net charges of $12,975, relating to a $15,408 charge for restructuring partially offset by a gain recognized on the extinguishment of debt of $2,433.

	1.		I have reviewed this Quarterly Report on Form 10-Q for the period ended March 31, 2009 of Human Genome Sciences, Inc.;

	2.		Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

	3.		Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

	4.		The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

	(a)		Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

	(b)		Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

	(c)		Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

	(d)		Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

	(a)		All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

	(b)		Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.



	/s/ H. Thomas Watkins
	H. Thomas Watkins
	President and Chief Executive Officer (Principal Executive Officer)

(1)		The Report fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and

(2)		The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.



	/s/ H. Thomas Watkins
	Name:	H. Thomas Watkins
	Date: May 5, 2009